ArticlePDF Available

Prevention of Type 2 Diabetes Mellitus by Changes in Lifestyle Among Subjects with Impaired Glucose Tolerance

Authors:

Abstract and Figures

Type 2 diabetes mellitus is increasingly common, primarily because of increases in the prevalence of a sedentary lifestyle and obesity. Whether type 2 diabetes can be prevented by interventions that affect the lifestyles of subjects at high risk for the disease is not known. We randomly assigned 522 middle-aged, overweight subjects (172 men and 350 women; mean age, 55 years; mean body-mass index [weight in kilograms divided by the square of the height in meters], 31) with impaired glucose tolerance to either the intervention group or the control group. Each subject in the intervention group received individualized counseling aimed at reducing weight, total intake of fat, and intake of saturated fat and increasing intake of fiber and physical activity. An oral glucose-tolerance test was performed annually; the diagnosis of diabetes was confirmed by a second test. The mean duration of follow-up was 3.2 years. The mean (+/-SD) amount of weight lost between base line and the end of year 1 was 4.2+/-5.1 kg in the intervention group and 0.8+/-3.7 kg in the control group; the net loss by the end of year 2 was 3.5+/-5.5 kg in the intervention group and 0.8+/-4.4 kg in the control group (P<0.001 for both comparisons between the groups). The cumulative incidence of diabetes after four years was 11 percent (95 percent confidence interval, 6 to 15 percent) in the intervention group and 23 percent (95 percent confidence interval, 17 to 29 percent) in the control group. During the trial, the risk of diabetes was reduced by 58 percent (P<0.001) in the intervention group. The reduction in the incidence of diabetes was directly associated with changes in lifestyle. Type 2 diabetes can be prevented by changes in the lifestyles of high-risk subjects.
Content may be subject to copyright.
The New England
Journal
of
Medicine
Copyright © 2001 by the Massachusetts Medical Society
VOLUME 344
M
AY
3, 2001
NUMBER 18
N Engl J Med, Vol. 344, No. 18
·
May 3, 2001
·
www.nejm.org
·
1343
PREVENTION OF TYPE 2 DIABETES MELLITUS BY CHANGES IN LIFESTYLE
AMONG SUBJECTS WITH IMPAIRED GLUCOSE TOLERANCE
J
AAKKO
T
UOMILEHTO
, M.D., P
H
.D., J
AANA
L
INDSTRÖM
, M.S., J
OHAN
G. E
RIKSSON
, M.D., P
H
.D., T
IMO
T. V
ALLE
, M.D.,
H
ELENA
H
ÄMÄLÄINEN
, M.D., P
H
.D., P
IRJO
I
LANNE
-P
ARIKKA
, M.D., S
IRKKA
K
EINÄNEN
-K
IUKAANNIEMI
, M.D., P
H
.D.,
M
AURI
L
AAKSO
, M.D., A
NNE
L
OUHERANTA
, M.S., M
ERJA
R
ASTAS
, M.S., V
IRPI
S
ALMINEN
, M.S.,
AND
M
ATTI
U
USITUPA
, M.D., P
H
.D.,
FOR
THE
F
INNISH
D
IABETES
P
REVENTION
S
TUDY
G
ROUP
A
BSTRACT
Background
Type 2 diabetes mellitus is increasing-
ly common, primarily because of increases in the prev-
alence of a sedentary lifestyle and obesity. Whether
type 2 diabetes can be prevented by interventions that
affect the lifestyles of subjects at high risk for the dis-
ease is not known.
Methods
We randomly assigned 522 middle-aged,
overweight subjects (172 men and 350 women; mean
age, 55 years; mean body-mass index [weight in kilo-
grams divided by the square of the height in meters],
31) with impaired glucose tolerance to either the in-
tervention group or the control group. Each subject in
the intervention group received individualized coun-
seling aimed at reducing weight, total intake of fat,
and intake of saturated fat and increasing intake of fi-
ber and physical activity. An oral glucose-tolerance
test was performed annually; the diagnosis of diabe-
tes was confirmed by a second test. The mean dura-
tion of follow-up was 3.2 years.
Results
The mean (±SD) amount of weight lost be-
tween base line and the end of year 1 was 4.2±5.1 kg
in the intervention group and 0.8±3.7 kg in the control
group; the net loss by the end of year 2 was 3.5±5.5 kg
in the intervention group and 0.8±4.4 kg in the control
group (P<0.001 for both comparisons between the
groups). The cumulative incidence of diabetes after
four years was 11 percent (95 percent confidence in-
terval, 6 to 15 percent) in the intervention group and
23 percent (95 percent confidence interval, 17 to 29
percent) in the control group. During the trial, the risk
of diabetes was reduced by 58 percent (P<0.001) in
the intervention group. The reduction in the incidence
of diabetes was directly associated with changes in
lifestyle.
Conclusions
Type 2 diabetes can be prevented by
changes in the lifestyles of high-risk subjects. (N Engl
J Med 2001;344:1343-50.)
Copyright © 2001 Massachusetts Medical Society.
From the Diabetes and Genetic Epidemiology Unit, Department of Ep-
idemiology and Health Promotion, National Public Health Institute, Hel-
sinki (J.T., J.L., J.G.E., T.T.V.); the Department of Public Health, University
of Helsinki (J.T.); the Research and Development Center, Social Insurance
Institution, Turku (H.H., M.R.); the Department of Internal Medicine,
Finnish Diabetes Association and Tampere University Hospital, Tampere
(P.I.-P.); the Department of Public Health Science and General Practice,
University of Oulu, and the Unit of General Practice, Oulu University
Hospital, Oulu (S.K.-K., M.L.); the Department of Clinical Nutrition,
University of Kuopio, Kuopio (A.L., M.U.); and the Institute of Nursing
and Health Care, Tampere (V.S.) — all in Finland. Address reprint requests
to Professor Tuomilehto at the National Public Health Institute, Depart-
ment of Epidemiology and Health Promotion, Diabetes and Genetic Epi-
demiology Unit, Mannerheimintie 166, FIN-00300 Helsinki, Finland, or
at jaakko.tuomilehto@ktl.fi.
Other authors were Sirkka Aunola, Ph.D., Research and Development
Center, Social Insurance Institution, Turku; Zygimantas Cepaitis, Dipl.Eng.,
and Vladislav Moltchanov, Ph.D., Diabetes and Genetic Epidemiology Unit,
Department of Epidemiology and Health Promotion, National Public Health
Institute, Helsinki; Martti Hakumäki, M.D., Ph.D., Department of Clinical
Nutrition, University of Kuopio, Kuopio; Marjo Mannelin, M.S., and Vesa
Martikkala, M.S., Department of Sports Medicine, Oulu Deaconess Insti-
tute, Oulu; and Jouko Sundvall, M.S., Department of Biochemistry, Na-
tional Public Health Institute, Helsinki all in Finland.
HE incidence of type 2 diabetes mellitus is
increasing worldwide. Type 2 diabetes re-
sults from the interaction between a genetic
predisposition and behavioral and environ-
mental risk factors.
1
Although the genetic basis of
type 2 diabetes has yet to be identified, there is strong
evidence that such modifiable risk factors as obesity
and physical inactivity are the main nongenetic de-
terminants of the disease.
2-9
Impaired glucose tolerance is an intermediate cat-
egory between normal glucose tolerance and overt
diabetes,
10,11
and it can be identified by an oral glucose-
tolerance test. Subjects with impaired glucose toler-
ance have an increased risk of type 2 diabetes
12
and
therefore form an important target group for inter-
ventions aimed at preventing diabetes.
2-5
The Finnish
Diabetes Prevention Study was conducted to deter-
mine the feasibility and effects of a program of chang-
T
Copyright © 2001 Massachusetts Medical Society. All rights reserved.
Downloaded from www.nejm.org by NGA T. NGUYEN MD on July 31, 2007 .
1344
·
N Engl J Med, Vol. 344, No. 18
·
May 3, 2001
·
www.nejm.org
The New England Journal of Medicine
es in lifestyle designed to prevent or delay the onset
of type 2 diabetes in subjects with impaired glucose
tolerance.
METHODS
Study Design
The design of the Diabetes Prevention Study has been described
in detail elsewhere.
13
The study was designed on the assumptions
of a 35 percent cumulative incidence of diabetes and a 35 percent
reduction in incidence in the intervention group, as compared with
the control group, during a six-year period. The study protocol was
approved by the ethics committee of the National Public Health
Institute in Helsinki, Finland, and all the study subjects gave writ-
ten informed consent.
Study subjects were recruited primarily through the screening of
members of high-risk groups, such as first-degree relatives of pa-
tients with type 2 diabetes. Overweight persons (defined as those
with a body-mass index [the weight in kilograms divided by the
square of the height in meters] of 25 or higher) who were 40 to
65 years old and had impaired glucose tolerance were eligible for
the study. Impaired glucose tolerance was defined as a plasma glu-
cose concentration of 140 to 200 mg per deciliter (7.8 to 11.0 mmol
per liter) two hours after the oral administration of 75 g of glucose
in subjects whose plasma glucose concentration after an overnight
fast was less than 140 mg per deciliter.
14
The test was repeated in
subjects in whom the first result was abnormal, and the mean of
the two values was used to determine eligibility. Criteria for exclu-
sion were a diagnosis of diabetes mellitus, the presence of chronic
disease rendering survival for six years unlikely, and other charac-
teristics (psychological or physical disabilities) deemed likely to in-
terfere with participation in the study.
Subjects who enrolled in the study were randomly assigned to
the intervention group or the control group by the study physician,
with the use of a randomization list, with stratification according
to center, sex, and the mean plasma glucose concentration two hours
after oral glucose challenge (140 to 169 mg per deciliter or 170
to 200 mg per deciliter [7.8 to 9.4 mmol per liter or 9.5 to 11.0
mmol per liter]). The nurses who scheduled the study visits did
not have access to the randomization list. However, the staff mem-
bers involved in the intervention had to be aware of the group
assignment; thus, the study was only partly blinded. Laboratory
staff did not know the subjects’ group assignments, and the subjects
were not informed of their plasma glucose concentrations during
follow-up unless diabetes was diagnosed.
A total of 523 subjects in five study centers were randomly as-
signed to one of the two treatment groups. The end-points com-
mittee excluded one subject who had diabetes at base line whose
diagnosis of diabetes was confirmed at her two-year visit. The sub-
jects in the control group were given general oral and written in-
formation about diet (a two-page leaflet) and exercise at base line
and at subsequent annual visits, but no specific individualized pro-
grams were offered to them. They completed a three-day food diary
at base line and at each annual visit, using a booklet illustrating the
sizes of portions of food.
15
Nutrient intakes were computed with
the use of a program developed at the National Public Health In-
stitute.
16
The subjects in the intervention group were given detailed ad-
vice about how to achieve the goals of the intervention, which were
a reduction in weight of 5 percent or more, in total intake of fat to
less than 30 percent of energy consumed, and in intake of saturated
fat to less than 10 percent of energy consumed; an increase in fiber
intake to at least 15 g per 1000 kcal; and moderate exercise for at
least 30 minutes per day. Frequent ingestion of whole-grain prod-
ucts, vegetables, fruits, low-fat milk and meat products, soft mar-
garines, and vegetable oils rich in monounsaturated fatty acids was
recommended. The dietary advice was tailored to each subject on
the basis of three-day food records completed four times per year.
Each subject in the intervention group had seven sessions with a
nutritionist during the first year of the study and one session every
three months thereafter. These subjects also received individual
guidance on increasing their level of physical activity. Endurance
exercise (such as walking, jogging, swimming, aerobic ball games,
or skiing) was recommended as a way to increase aerobic capacity
and improve cardiorespiratory fitness. Supervised, progressive, in-
dividually tailored, circuit-type resistance-training sessions were also
offered with the aim of improving the functional capacity and
strength of the large muscle groups; subjects were instructed to per-
form a moderate to high number of repetitions and to take a break
of 15 to 60 seconds between the stations on the circuit. During the
first year, the rate of participation in these sessions varied from 50
percent to 85 percent at different centers.
If, at an annual visit, the study physician discovered a clinical con-
dition that required attention, such as a high serum cholesterol con-
centration or hypertension, the subject was advised to contact his or
her own physician for treatment and follow-up.
Clinical Studies
At base line and at each annual visit, all study subjects completed
a medical-history questionnaire and underwent a physical exami-
nation that included anthropometric and blood-pressure measure-
ments and an oral glucose-tolerance test, as described elsewhere.
13
Biochemical Assessments
Plasma glucose was measured at each center by means of stand-
ard methods. The glucose measurements were standardized by the
central laboratory in Helsinki, whose staff analyzed 60 to 80 plasma
samples from each center in duplicate. A linear-regression equation
was calculated for each center, with the use of the plasma glucose
measurement determined at the Helsinki laboratory as the standard.
These equations were used to correct the locally measured plasma
glucose values. The result of the second oral glucose-tolerance test
was considered the base-line value for comparison with values ob-
tained later; in some subjects whose entry into the study was de-
layed, a third oral glucose-tolerance test was performed whose result
was considered the base-line value. The serum insulin concentration
was measured by a radioimmunoassay (Pharmacia, Uppsala, Swe-
den), and serum levels of total cholesterol, high-density lipoprotein
cholesterol, and triglycerides were measured by enzymatic assay in
the central laboratory in Helsinki.
Assessment of the End Points
Diabetes was defined according to the 1985 criteria of the World
Health Organization
14
as either a fasting plasma glucose concentra-
tion of 140 mg per deciliter or higher or a plasma glucose concen-
tration of 200 mg per deciliter or higher two hours after an oral
glucose challenge. We required confirmation of the diagnosis of
diabetes by a second oral glucose-tolerance test; if the diagnosis was
not confirmed by the second test, the subject followed the program
according to the original random assignment. The diagnosis of
diabetes was based on the locally measured plasma glucose values,
since these were used for the inclusion of subjects in the study. In
the statistical analysis, corrected plasma glucose values were used.
The independent end-points committee confirmed all newly diag-
nosed cases of diabetes. The study centers did not exchange infor-
mation concerning the number of subjects who reached the end
point, and the end-point data were linked to the group assignment
at the study center only after a total of 80 subjects had reached the
end point, as stated in the study plan.
Statistical Analysis
In March 2000, an independent statistician completed the first
analysis of data, which included all cases of diabetes diagnosed be-
fore that date. On the basis of the results of this analysis, the end-
points committee recommended that the trial be ended.
Two-sided t-tests and chi-square tests were used to analyze the
differences between the groups at base line and during follow-up.
Survival curves were calculated to estimate the cumulative incidence
of diabetes. The difference between the groups in the incidence of
Copyright © 2001 Massachusetts Medical Society. All rights reserved.
Downloaded from www.nejm.org by NGA T. NGUYEN MD on July 31, 2007 .
THIS MATERIAL MAY BE
PROTECTED BY COPYRIGHT
LAW (17 USC)
LIFESTYLE CHANGES TO PREVENT TYPE 2 DIABETES AMONG SUBJECTS WITH IMPAIRED GLUCOSE TOLERANCE
N Engl J Med, Vol. 344, No. 18
·
May 3, 2001
·
www.nejm.org
·
1345
diabetes was tested by means of the two-sided log-rank test. All
analyses of end points were based on the intention-to-treat prin-
ciple. The SAS PHREG procedure was used to derive the basic es-
timates, such as the survival functions and the 95 percent confidence
limits of the estimates (SAS/STAT software, version 6.12, SAS In-
stitute, Cary, N.C.). Subjects who withdrew from the study were
considered to be at risk for diabetes until their last oral glucose-
tolerance test, at which point data were censored. To estimate the
extent of the dependence of the incidence of diabetes on the chang-
es in lifestyle that were achieved, subjects were given a grade for each
goal of the intervention at the one-year visit (with 0 indicating that
it was not achieved or 1 indicating that it was achieved), and a suc-
cess score was computed as the sum of these grades. For each sub-
group defined according to success score, the proportion of subjects
in whom diabetes had developed was calculated. To test for a sta-
tistical association between this proportion and the success score,
logistic-regression analysis was performed with the use of the SAS
GENMOD procedure. The expected proportion was modeled as
a linear function of the success score.
RESULTS
The first subject was assigned to a group in Novem-
ber 1993 and the last in June 1998. At that time, 90
percent of the study subjects had been enrolled in the
trial for at least 2 years, and the mean duration of fol-
low-up was 3.2 years. The base-line characteristics of
the two groups were similar (Table 1). During the
first year, the mean (±SD) body weight decreased by
4.2±5.1 kg (4.7±5.4 percent) in the intervention
group and by 0.8±3.7 kg (0.9±4.2 percent) in the
control group (P<0.001) (Table 2). Waist circumfer-
ence, the fasting plasma glucose concentration, the
plasma glucose concentration two hours after oral glu-
cose challenge, and the serum insulin concentration
two hours after glucose challenge decreased signifi-
cantly more among subjects in the intervention group
than among those in the control group. At two years,
the decrease in weight remained significantly greater
in the intervention group (3.5±5.5 kg) than in the
control group (0.8±4.4 kg) (P<0.001). At this time,
the mean change from base line in the fasting plasma
glucose concentration was –2±12 mg per deciliter
(–0.1±0.7 mmol per liter) in the intervention group
and +3±14 mg per deciliter (+0.2±0.8 mmol per li-
ter) in the control group (P<0.001); the change in the
plasma glucose concentrations measured two hours
after oral glucose challenge was 14±37 mg per dec-
iliter (–0.8±2.1 mmol per liter) in the intervention
group and +0±44 mg per deciliter (+0±2.5 mmol
per liter) in the control group (P<0.001). There were
also significantly greater decreases in the intervention
group than in the control group in the serum insulin
concentration two hours after oral glucose challenge,
as well as in the triglyceride concentration and blood
pressure (data not shown).
The study subjects were asked about their health-
related behavior at base line and subsequently at each
annual follow-up examination (Table 3). The sub-
jects in the intervention group were more likely to
report changes in dietary and exercise habits. Success
in achieving the goals of the intervention was estimat-
ed on the basis of the food records and exercise ques-
tionnaires collected at the one-year examination (Ta-
ble 4). The proportion of subjects in the intervention
group who succeeded in achieving a particular goal
varied from 25 percent (fiber intake) to 86 percent
(exercise).
Diabetes was diagnosed in a total of 86 subjects —
27 in the intervention group and 59 in the control
group. The average proportion of subjects in whom
impaired glucose tolerance progressed to diabetes was
3 percent per year in the intervention group and 6 per-
cent per year in the control group. The absolute inci-
dence of diabetes was 32 cases per 1000 person-years
in the intervention group and 78 per 1000 person-
years in the control group.
The cumulative incidence of diabetes was lower in
the intervention group than in the control group (Fig.
1). The difference was statistically significant after two
years: 6 percent in the intervention group (95 per-
*Plus–minus values are means ±SD. To convert values for glucose to
millimoles per liter, multiply by 0.056. To convert values for insulin to pi-
comoles per liter, multiply by 6. To convert values for cholesterol to milli-
moles per liter, multiply by 0.026. To convert values for triglycerides to
millimoles per liter, multiply by 0.011.
†Cholesterol-lowering drugs were being taken by 5 percent of the sub-
jects in the intervention group and 6 percent of the subjects in the control
group at base line.
‡Antihypertensive drugs were being taken by 30 percent of the subjects
in the intervention group and 31 percent of the subjects in the control
group at base line.
§P=0.03 for the comparison with the intervention group by two-tailed
t-test.
T
ABLE
1.
B
ASE
-L
INE
C
HARACTERISTICS
OF
THE
S
UBJECTS
IN
THE
I
NTERVENTION
AND
C
ONTROL
G
ROUPS
.*
C
HARACTERISTIC
I
NTERVENTION
G
ROUP
(N=265)
C
ONTROL
G
ROUP
(N=257)
Sex (no.)
Male
Female
91
174
81
176
Age (yr) 55±7 55±7
Body-mass index 31.3±4.6 31.0±4.5
Waist circumference (cm) 102.0±11.0 100.5±10.9
Hip circumference (cm) 110.4±10.5 109.4±9.7
Plasma glucose (mg/dl)
Fasting
2 Hr after oral glucose challenge
109±14
159±27
110±13
159±26
Serum insulin (
m
U/ml)
Fasting
2 Hr after oral glucose challenge
15±7
98±74
15±8
93±54
Serum lipids (mg/dl)†
Total cholesterol
High-density lipoprotein cholesterol
Triglycerides
215±37
46±12
154±72
215±35
47±11
158±69
Blood pressure (mm Hg)‡
Systolic
Diastolic
140±18
86±9
136±17§
86±10
Copyright © 2001 Massachusetts Medical Society. All rights reserved.
Downloaded from www.nejm.org by NGA T. NGUYEN MD on July 31, 2007 .
1346
·
N Engl J Med, Vol. 344, No. 18
·
May 3, 2001
·
www.nejm.org
The New England Journal of Medicine
cent confidence interval, 3 to 9 percent) and 14 per-
cent in the control group (95 percent confidence in-
terval, 10 to 19 percent). At four years, the cumulative
incidence was 11 percent (95 percent confidence in-
terval, 6 to 15 percent) in the intervention group and
23 percent (95 percent confidence interval, 17 to 29
percent) in the control group. According to the Cox
regression analysis of all person-years accumulated,
the cumulative incidence of diabetes was 58 percent
lower in the intervention group than in the control
group (hazard ratio, 0.4; 95 percent confidence inter-
val, 0.3 to 0.7; P<0.001). The incidence of diabetes
was 63 percent lower among men in the intervention
group (95 percent confidence interval, 18 to 79 per-
cent; P=0.01) and 54 percent lower among women
(95 percent confidence interval, 26 to 81 percent;
P=0.008).
The study subjects were ranked according to their
success in achieving the goals of the intervention (and
given a success score between 0 and 5) at the one-year
examination, with higher scores indicating more goals
met (Fig. 2). There was a strong inverse correlation be-
tween the success score and the incidence of diabetes.
Thirteen subjects in the intervention group and 48
subjects in the control group did not achieve any of
the goals; diabetes developed in 38 percent and 31
*A total of 15 subjects withdrew from the study within the first year; 1 additional subject did not undergo testing at
one year, although she remained in the study. To convert values for glucose to millimoles per liter, multiply by 0.056. To
convert values for insulin to picomoles per liter, multiply by 6. To convert values for cholesterol to millimoles per liter,
multiply by 0.026. To convert values for triglycerides to millimoles per liter, multiply by 0.011. CI denotes confidence
interval.
†P values were determined by a two-tailed t-test for the difference between the groups.
‡Cholesterol-lowering drugs were being taken by 6 percent of the subjects in the intervention group and 8 percent of
those in the control group by the end of year 1.
§Antihypertensive drugs were being taken by 30 percent of the subjects in the intervention group and 31 percent of
those in the control group by the end of year 1.
T
ABLE
2.
C
HANGES
IN
S
ELECTED
C
LINICAL
AND
M
ETABOLIC
V
ARIABLES
FROM
B
ASE
-L
INE
TO
THE
E
ND
OF
Y
EAR
1
IN
THE
S
UBJECTS
IN
THE
I
NTERVENTION
AND
C
ONTROL
G
ROUPS
.*
VARIABLE
INTERVENTION GROUP
(N=256)
CONTROL GROUP
(N=250) P VALUE
mean ±SD 95% CI mean ±SD 95% CI
Change in weight
In kilograms
Percent change
¡4.2±5.1
¡4.7±5.4
¡4.8 to ¡3.6
¡5.0 to ¡4.4
¡0.8±3.7
¡0.9±4.2
¡1.3 to ¡0.3
¡1.0 to ¡0.8
<0.001
<0.001
Change in waist circumference (cm) ¡4.4±5.2 ¡5.1 to ¡3.9 ¡1.3±4.8 ¡1.9 to ¡0.7 <0.001
Change in plasma glucose (mg/dl)
Fasting
2 Hr after oral glucose challenge
¡4±12
¡15±34
¡6 to ¡2
¡19 to ¡11
1±12
¡5±40
0 to 2
¡8 to ¡2
<0.001
0.003
Change in serum insulin (mg/ml)
Fasting
2 Hr after oral glucose challenge
¡2±9
¡29±64
¡3 to ¡1
¡37 to ¡21
¡1±7
¡11±51
¡2 to 0
¡18 to ¡4
0.14
0.001
Change in serum lipids (mg/dl)‡
Total cholesterol
High-density lipoprotein cholesterol
Triglycerides
¡5±28
2±7
¡18±51
¡8 to ¡2
1 to 3
¡24 to ¡12
¡4±28
1±6
¡1±60
¡7 to ¡1
0 to 2
¡8 to 6
0.62
0.06
0.001
Change in blood pressure (mm Hg)§
Systolic
Diastolic
¡5±14
¡5±9
¡7 to ¡3
¡6 to ¡4
¡1±15
¡3±9
¡3 to 1
¡4 to ¡2
0.007
0.02
*Seven subjects of 507 who remained in the study at one year had some
missing data and are not included in this table.
†P values were determined by the chi-square test for the difference be-
tween the groups.
‡Subjects reported the frequency of exercise in terms of a shift to a high-
er category of the following four categories: (1) “I read, watch television,
and work in the household at tasks that don’t strain me physically”; (2)
“I walk, cycle, or exercise lightly in other ways at least four hours per
week”; (3) “I exercise to maintain my physical condition by running, jog-
ging, skiing, doing gymnastics, swimming, playing ball games, etc., for at
least 3 hours per week”; or (4) “I exercise competitively several times a
week by running, orienteering, skiing, playing ball games, or engaging in
other sports involving heavy exertion.
TABLE 3. SELF-REPORTED CHANGE IN DIETARY AND EXERCISE
HABITS DURING THE FIRST YEAR OF THE INTERVENTION,
ACCORDING TO TREATMENT GROUP.*
VARIABLE
INTERVENTION
G
ROUP
(N=253)
C
ONTROL
G
ROUP
(N=247) P V
ALUE
% of subjects
Decreased consumption of fat 87 70 0.001
Changed the quality of fat 70 39 0.001
Increased consumption of vegetables 72 62 0.01
Decreased consumption of sugar 55 40 0.001
Decreased consumption of salt 59 50 0.03
Decreased consumption of alcohol 26 23 0.43
Increased exercise‡ 36 16 0.001
Copyright © 2001 Massachusetts Medical Society. All rights reserved.
Downloaded from www.nejm.org by NGA T. NGUYEN MD on July 31, 2007 .
LIFESTYLE CHANGES TO PREVENT TYPE 2 DIABETES AMONG SUBJECTS WITH IMPAIRED GLUCOSE TOLERANCE
N Engl J Med, Vol. 344, No. 18 · May 3, 2001 · www.nejm.org · 1347
percent of these subjects, respectively, during follow-
up. Diabetes had not developed in any of the subjects
who reached four or five of the goals (49 subjects in
the intervention group and 15 in the control group).
According to a univariate analysis, the odds ratio for
diabetes in subjects in the intervention group who had
lost more than 5 percent of their initial weight by the
one-year follow-up visit was 0.3 (95 percent confi-
dence interval, 0.1 to 0.7) as compared with those in
the intervention group who had lost less weight or
none at all; the corresponding odds ratio in the con-
trol group was 0.4 (95 percent confidence interval,
0.1 to 1.2). Among the subjects in the intervention
group who did not reach the goal of losing 5 percent
of their initial weight, the odds ratio for diabetes in
those who had achieved the goal with respect to exer-
cise (more than four hours per week) during the first
year was 0.2 (95 percent confidence interval, 0.1 to
0.6) as compared with those in the intervention group
who maintained a sedentary lifestyle; the correspond-
ing odds ratio in the control group was 0.6 (95 per-
cent confidence interval, 0.3 to 1.1). After adjustment
*Nutrient intakes were calculated from three-day food records.
†P values were determined by the chi-square test for the difference be-
tween the groups.
‡Exercise frequency was reported by the subjects who chose one of the
four categories described in Table 3. The goal identified here was a fre-
quency in category 2 or higher.
TABLE 4. SUCCESS IN ACHIEVING THE GOALS
OF THE INTERVENTION BY ONE YEAR,
ACCORDING TO TREATMENT GROUP.*
GOAL
INTERVENTION
G
ROUP
CONTROL
G
ROUP P VALUE
% of subjects
Weight reduction >5% 43 13 0.001
Fat intake <30% of energy intake 47 26 0.001
Saturated-fat intake <10% of energy
intake
26 11 0.001
Fiber intake »15 g/1000 kcal 25 12 0.001
Exercise >4 hr/wk‡ 86 71 0.001
Figure 1. Proportion of Subjects without Diabetes during the Trial.
The vertical bars show the 95 percent confidence intervals for the cumulative probability of remaining
free of diabetes. The relative risk of diabetes for subjects in the intervention group, as compared with
those in the control group, was 0.4 (P<0.001 for the comparison between the groups).
0.4
1.0
6
0.5
0.6
0.7
0.8
0.9
1 2 3
Control group
Intervention group
4 50
Study Year
SUBJECTS AT RISK
Total no.
Cumulative no. with diabetes:
Intervention group
Control group
507
5
16
471
15
37
374
22
51
167
24
53
53
27
57
27
27
59
Cumulative Probability of
Remaining Free of Diabetes
Copyright © 2001 Massachusetts Medical Society. All rights reserved.
Downloaded from www.nejm.org by NGA T. NGUYEN MD on July 31, 2007 .
1348 · N Engl J Med, Vol. 344, No. 18 · May 3, 2001 · www.nejm.org
The New England Journal of Medicine
for base-line body-mass index, the odds ratio for di-
abetes in those in the intervention group who had
achieved the exercise goal was still statistically signif-
icant (odds ratio, 0.3; 95 percent confidence interval,
0.1 to 0.7).
During the study, 40 subjects (8 percent) withdrew
— 23 in the intervention group and 17 in the control
group. Of these subjects, 9 could not be contacted,
3 withdrew due to severe illness, 1 died, and 27 with-
drew for personal reasons.
DISCUSSION
This study provides evidence that type 2 diabetes
can be prevented by changes in the lifestyles of both
women and men at high risk for the disease. The over-
all incidence of diabetes was reduced by 58 percent.
Our estimate of the effect of the intervention can be
considered conservative for two reasons. First, the data
were analyzed according to the intention-to-treat prin-
ciple, even though some subjects in the intervention
group did not follow the recommendations about diet
and exercise. Second, for ethical reasons, all subjects
assigned to the control group also received general
health advice at base line and at annual follow-up
visits and may have benefited from this advice.
The results from previous studies in Sweden
17
and
China
18
also provide evidence that changes in lifestyle
are effective in preventing diabetes, and the magnitude
of the benefit in these studies was similar to that in
our study. In those two studies, the subjects were not
randomly assigned to the intervention and control
groups. The randomization in our study was stratified
according to clinic, sex, and base-line plasma glucose
concentration two hours after oral glucose challenge
in order to obtain the best possible comparability be-
tween groups. In the Chinese study,
18
an attempt to
Figure 2. Incidence of Diabetes during Follow-up, According to the Success Score.
At the one-year visit, each subject received a grade of 0 for each intervention goal that had not been
achieved and a grade of 1 for each goal that had been achieved; the success score was computed as
the sum of the grades. Forty subjects who withdrew from the study when their diabetes status was
unknown and 14 subjects with incomplete data were excluded from this analysis. The association be-
tween the success score and the risk of diabetes, with 95 percent confidence intervals, was estimated
by means of logistic-regression analysis of the observed data. The curves show the model-based in-
cidence of diabetes according to the success score as a continuous variable; the curve whose data
points align with the open bars represents the model-based incidence for the control group, and the
curve whose data points align with the shaded bars represents the model-based incidence for the in-
tervention group.
0
50
05
10
20
30
40
1 2 3 4
Success Score
NO. WITH DIABETES / TOTAL NO.
Intervention group
Control group
5/13
15/48
10/66
25/107
9/69
14/48
2/38
2/15
0/25
0/11
0/24
0/4
Incidence of Diabetes (%)
Control group
Intervention group
Copyright © 2001 Massachusetts Medical Society. All rights reserved.
Downloaded from www.nejm.org by NGA T. NGUYEN MD on July 31, 2007 .
LIFESTYLE CHANGES TO PREVENT TYPE 2 DIABETES AMONG SUBJECTS WITH IMPAIRED GLUCOSE TOLERANCE
N Engl J Med, Vol. 344, No. 18 · May 3, 2001 · www.nejm.org · 1349
determine whether a change in diet or a change in
exercise habits was more effective found no differ-
ence in outcome between the two interventions. We
did not try to separate these changes but, rather, tried
to achieve changes in lifestyle that were as extensive as
possible for each subject.
The effect of the interventions was assessed after one
year because earlier assessment may be biased as a re-
sult of changes made only because subjects are con-
scious of being studied. The effect of the intervention
on the incidence of diabetes was most pronounced
among subjects who made comprehensive changes in
lifestyle; on the other hand, the failure to make any
changes resulted in an incidence of diabetes that was
close to the estimate of 35 percent for this high-risk
population. The average amount of weight lost was
not large, yet the difference between the incidence
of diabetes in the intervention group and that in the
control group was substantial. The low odds ratio
for diabetes among those who lost at least 5 percent
of their initial weight reveals the importance of even
a relatively small reduction in weight in the preven-
tion of diabetes.
Our counseling regarding physical exercise includ-
ed components designed to improve both cardiores-
piratory fitness and muscle strength. Achieving a rel-
atively conservative target of more than four hours
of exercise per week was associated with a significant
reduction in the risk of diabetes in the subjects who
did not lose weight. It is likely that any type of phys-
ical activity — whether sports, household work, gar-
dening, or work-related physical activity is simi-
larly beneficial in preventing diabetes. Many subjects
with impaired glucose tolerance are both obese and
inactive, and therefore we would expect to find a
dose–response relation between the correction of
these multiple risk factors and reductions in the risk
of diabetes.
The main justification for the type of intervention
used in the high-risk subjects in this study is that it
may prevent or postpone the onset of type 2 diabe-
tes and the complications related to the disease. Pa-
tients with diabetes — with or without symptoms
have an increased prevalence of both macrovascular
and microvascular complications at the time when
diabetes is diagnosed. Many also have hypertension
and an atherogenic serum lipid profile.
19-22
The chang-
es in lifestyle in our study not only improved glucose
tolerance but also reduced the magnitude of several
other cardiovascular risk factors.
13
It is commonly ar-
gued that it is difficult to change the lifestyle of obese
and sedentary people, but such pessimism may not
be justified. The reasonably low dropout rate in our
study also indicates that subjects with impaired glu-
cose tolerance are willing and able to participate in a
demanding intervention program if it is made avail-
able to them.
It is possible to achieve primary prevention of
type 2 diabetes by means of a nonpharmacologic in-
tervention that can be implemented in a primary
health care setting. According to our results, 22 sub-
jects with impaired glucose tolerance must be treated
in this way for one year — or 5 subjects for five years
to prevent one case of diabetes.
Supported by the Finnish Academy (grants 8473/2298, 40758/5767,
and 38387/54175), the Ministry of Education, the Novo Nordisk Foun-
dation, the Yrjö Jahnsson Foundation, and the Finnish Diabetes Research
Foundation.
We are indebted to Ms. Kirsi Frantsi, Mr. Olli Heinonen, Ms.
Katri Hemiö, Ms. Pirjo Härkönen, Ms. Pia Högström, Ms. Anja Il-
manen, Ms. Kaija Kettunen, Ms. Paivi Kleemola, Ms. Anna Kor-
honen, Ms. Marjukka Lauhkonen, Ms. Pirjo Lehto, Ms. Liisa Mikkola,
Ms. Paula Nyholm, and Ms. Arja Putila for their skillful assistance
in performing the study; to Dr. Timo Lakka and Professor Jukka T.
Salonen for their expert advice concerning the assessment of exercise;
to Professor Marja-Riitta Taskinen and Professor Antti Aro for their
participation on the end-points committee; and to Dr. William C.
Knowler for his important contribution to the planning of our study.
REFERENCES
1. Neel JV. Diabetes mellitus: a “thrifty” genotype rendered detrimental
by “progress”? Am J Hum Genet 1962;14:353-62.
2. Tuomilehto J, Wolf E. Primary prevention of diabetes mellitus. Diabetes
Care 1987;10:238-48.
3. King H, Dowd JE. Primary prevention of type 2 (non-insulin-depend-
ent) diabetes mellitus. Diabetologia 1990;33:3-8.
4. Tuomilehto J, Tuomilehto-Wolf E, Zimmet P, Alberti K, Knowler W.
Primary prevention of diabetes mellitus. In: Alberti K, Zimmet P, De-
Fronzo R , Keen H, eds. International textbook of diabetes mellitus. Chi-
chester, England: John Wiley, 1997:1799-827.
5. Hamman RF. Genetic and environmental determinants of non-insulin-
dependent diabetes mellitus (NIDDM). Diabetes Metab Rev 1992;8:287-
338.
6. Zimmet PZ. Primary prevention of diabetes mellitus. Diabetes Care
1988;11:258-62.
7. Stern MP. Kelly West Lecture: primary prevention of type II diabetes
mellitus. Diabetes Care 1991;14:399-410.
8. Ohlson LO, Larsson B, Björntorp P, et al. Risk factors for type 2 (non-
insulin-dependent) diabetes mellitus: thirteen and one-half years of follow-
up of the participants in a study of Swedish men born in 1913. Diabeto-
logia 1988;31:798-805.
9. Manson JE, Rimm EB, Stampfer MJ, et al. Physical activity and inci-
dence of non-insulin-dependent diabetes mellitus in women. Lancet 1991;
338:774-8.
10. Prevention of diabetes mellitus: report of a WHO study group. WHO
Tech Rep Ser 1994;844:1-100.
11. Harris MI. Impaired glucose tolerance in the U.S. population. Diabe-
tes Care 1989;12:464-74.
12. The DECODE Study Group. Glucose tolerance and mortality: com-
parison of WHO and American Diabetes Association diagnostic criteria.
Lancet 1999;354:617-21.
13. Eriksson J, Lindström J, Valle T, et al. Prevention of type II diabetes
in subjects with impaired glucose tolerance: the Diabetes Prevention Study
(DPS) in Finland: study design and 1-year interim report on the feasibility
of the lifestyle intervention programme. Diabetologia 1999;42:793-801.
14. Diabetes mellitus: report of a WHO study group. WHO Tech Rep Ser
1985;727:7-113.
15. Haapa E, Toponen T, Pietinen P, Räsänen L. Annoskuvakirja. Helsin-
ki, Finland: Painokaari Oy, 1985.
16. Ovaskainen M-L, Valsta L, Lauronen J. The compilation of food
analysis values as a database for dietary studies the Finnish experience.
Food Chem 1996;57:133-6.
17. Eriksson KF, Lindgarde F. Prevention of type 2 (non-insulin-depend-
ent) diabetes mellitus by diet and physical exercise: the 6-year Malmo fea-
sibility study. Diabetologia 1991;34:891-8.
18. Pan XR, Li GW, Hu YH, et al. Effects of diet and exercise in prevent-
ing NIDDM in people with impaired glucose tolerance: the Da Qing IGT
and Diabetes Study. Diabetes Care 1997;20:537-44.
19. Uusitupa M, Siitonen O, Aro A, Pyörälä K. Prevalence of coronary
heart disease, left ventricular failure and hypertension in middle-aged, new-
Copyright © 2001 Massachusetts Medical Society. All rights reserved.
Downloaded from www.nejm.org by NGA T. NGUYEN MD on July 31, 2007 .
1350 · N Engl J Med, Vol. 344, No. 18 · May 3, 2001 · www.nejm.org
The New England Journal of Medicine
ly diagnosed type 2 (non-insulin-dependent) diabetic subjects. Diabetolo-
gia 1985;28:22-7.
20. Harris MI. Undiagnosed NIDDM: clinical and public health issues.
Diabetes Care 1993;16:642-52.
21. Partanen J, Niskanen L, Lehtinen J, Mervaala E, Siitonen O, Uusitupa
M. Natural history of peripheral neuropathy in patients with non-insulin-
dependent diabetes mellitus. N Engl J Med 1995;333:89-94.
22. Haffner SM, Mykkänen L, Festa A, Burke JP, Stern MP. Insulin-resist-
ant prediabetic subjects have more atherogenic risk factors than insulin-
sensitive prediabetic subjects: implications for preventing coronary heart
disease during the prediabetic state. Circulation 2000;101:975-80.
Copyright © 2001 Massachusetts Medical Society.
Copyright © 2001 Massachusetts Medical Society. All rights reserved.
Downloaded from www.nejm.org by NGA T. NGUYEN MD on July 31, 2007 .
... There has been a sharp rise in the triad of childhood obesity, prediabetes, and overt type 2 diabetes (T2D) in children and adolescents in the United States [1][2][3][4]. The prevalence of prediabetes, the precursor of T2D, has risen significantly from 11.6% in 1999-2002 to 28.2% in 2015-2018 among US children and adolescents [5]. This sharp increase is on target to reach and exceed the current prevalence of prediabetes in adults of 34% [3,6]. ...
... In contrast, some studies in adults have demonstrated a short-term effect of decreasing the rate of progression of prediabetes to T2D. These include the institution of intensive glycemic control using basal insulin [27], lifestyle modification [28], diet and exercise [29], weight loss, metformin [30], orlistat [31], thiazolidinediones [32], and gastric bypass [33]. In contrast, interventions with meglitinides [34], acarbose [35], and sulfonylureas [36] showed less efficacy on reversing the progression from prediabetes to T2D. ...
Article
Full-text available
Prediabetes, the precursor of type 2 diabetes (T2D), is on the rise among children and adolescents in the United States. The natural history of prediabetes is poorly characterized in children compared to adults. The available data indicate a phenotype of an accelerated β-cell failure in youth with prediabetes. Data from randomized controlled trials showed no benefit on β-cell preservation or A1c in youth with prediabetes from therapeutic agents such as metformin and insulin. As a result, the American Diabetes Association recommends only lifestyle intervention, but not therapeutic agents, for the management of prediabetes in children and adolescents. These recommendations for lifestyle modification in youth, largely derived from data in adults, lack the precision necessary for efficacy in youth. However, a recent 4-year real-world study on youth reported that adherence to nutrition visits was associated with a 4-fold reduction in the likelihood of progressing from prediabetes to T2D. The finding that this reversal is associated with reduced insulin resistance (IR) and not with decreased body weight is novel and provides the foundation for trialing investigational products that may protect β-cells and reduce IR and/or body weight. This study provides the much-needed foundation for further exploration of the impact of lifestyle modification in conjunction with other approaches for the reversal of prediabetes in youth. The systematization of the protocol for medical nutrition therapy for the reversal of prediabetes in youth will ensure optimal and consistent results from adherent patients. This communication provides updates on the pathobiology of prediabetes in youth and a clear direction for efficacious studies in the field.
... The DPP lifestyle intervention was based on recommendations from the 1995 Dietary Guidelines for Americans and addressed similar areas as the 2018 WCRF/AICR Recommendations [17]. Many past studies investigated how changes in weight, diet quality, and PA individually impact diabetes risk; few studies have examined these lifestyle factors together [18,19]. DPP provides a unique opportunity to examine how lifestyle changes can affect diabetes risk. ...
Article
Background: The 2018 World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) 3rd expert report highlights up-to-date Cancer Prevention Recommendations that may reduce burdens of many chronic diseases, including diabetes. This study examined if following a lifestyle that aligns with the recommendations - assessed via the 2018 WCRF/AICR Score - was associated with lower risk of type 2 diabetes in high-risk adults participating in the Diabetes Prevention Program Outcomes Study (DPPOS). Methods: The Diabetes Prevention Program (DPP) randomized adults at high risk for diabetes to receive a lifestyle intervention (ILS), metformin (MET) or a placebo (PLB) (mean: 3.2 years), with additional follow-up in DPPOS for 11 years (mean: 15 years total). 2018 WCRF/AICR Scores included seven components: body weight, physical activity, plant-based foods, fast foods, red and processed meat, sugar-sweetened beverages, and alcohol; the optional breastfeeding component was excluded. Scores ranged 0-7 points (with greater scores indicating greater alignment with the recommendations) and were estimated at years 0, 1, 5, 6, 9, and 15 (N=3,147). Fasting glucose and HbA1c were measured every six months and oral glucose tolerance tests were performed annually. Adjusted Cox proportional hazard ratios (HRs) and 95% confidence intervals (CIs) were used to examine the association of both Score changes from years 0-1 and time-dependent Score changes on diabetes risk through DPP and year 15. Results: Scores improved within all groups over 15 years (p<0.001); ILS Scores improved more than MET or PLB Scores after 1 year (p<0.001). For every 1-unit improvement from years 0-1, there was a 31% and 15% lower diabetes risk in ILS (95% CI: 0.56-0.84) and PLB (95% CI: 0.72-0.97) through DPP, and no significant association in MET. Associations were greatest among American Indian participants, followed by non-Hispanic White and Hispanic participants. Score changes from years 0-1 and time-dependent Score changes in ILS and PLB remained associated with lower risk through year 15. Conclusions: Score improvements were associated with long-term, lower diabetes risk among high-risk adults randomized to ILS and PLB, but not MET. Future research should explore impact of the Score on cancer risk. Trial registration: Diabetes Prevention Program: NCT00004992 ; Diabetes Prevention Program Outcomes Study: NCT00038727.
... Previous studies reported that the prevalence of Type 2 diabetes can be reduced by approximately 50.0% by adopting healthy lifestyle behaviors in individuals in the prediabetic stage. 17,18 Behaviors such as physical activity, healthy nutrition, regular sleep, not using excessive alcohol, and nonsmoking are among the healthy lifestyle behaviors. ...
Article
Full-text available
Background: Adopting healthy lifestyle behaviors is an important step in preventing diseases.Objective: This study aims to determine healthy lifestyle behaviors, fasting blood glucose (FBG) levels, and waist circumference of employees in a public university in Turkiye.Methods: This descriptive study was conducted. A total of 191 academic and administrative staff were recruited for this study.We used sociodemographic data form and the Health-Promoting Lifestyle Profile II (HPLP II) for data collection. We measured and recorded each participant’s FBG (at least 8 hours), height, weight, and waist circumference in the data sheet.Results: Of the participants, 77% were aged under 40; 74.9% were male; 71.2% were administrative staff; 48.2% had FBG between 100-125 mg/dl.; 49.2% were within the normal BMI (Body Mass Index) range; 29.2% of women had a waist circumference greater than 90 cm, 25.2% of men had a waist circumference greater than 100 cm. The average HPLP II score of the participants was 128.67±18.51.Conclusion: It was determined that healthy lifestyle behaviors did not change according to age, that 48.2% of the participants had FBG between 100-125 mg/dl and were not aware of their blood glucose levels, that half of the participants were overweight and obese, and that waist circumference and FBG increased as BMI increased. The incidence of diabetes might be higher than predicted in guidelines in near future.International Journal of Human and Health Sciences Vol. 06 No. 04 Oct’22 Page: 383-392
... Physical activity plays an important role in the prevention and management of type 2 diabetes [8,9]. Long term studies (>8 weeks) of exercise training have shown improvements in insulin sensitivity and glycemic control, together with beneficial changes in cardiorespiratory fitness (VO2max), body composition, blood pressure, and lipid profile in patients with type 2 diabetes [4,[9][10][11]. ...
Preprint
Aim: Non-weight-bearing high-intensity interval training (HIIT) involving several muscle groups may efficiently improve metabolic health in obesity and type 2 diabetes. In a non-randomized intervention study, we examined the effect of a HIIT-protocol, recruiting both lower and upper body muscles, on insulin sensitivity, measures of metabolic health and adherence in obesity and type 2 diabetes. Methods: In 15 obese men with type 2 diabetes and age-matched obese (n=15) and lean (n=18) glucose-tolerant men, the effects of 8-weeks supervised HIIT combining rowing and cycling were examined by DXA-scan, exercise test and hyperinsulinemic-euglycemic clamp. Results: At baseline, insulin-stimulated glucose disposal rate (GDR) was ~40% reduced in the diabetic vs the non-diabetic groups (all p<0.01). In response to HIIT, insulin-stimulated GDR increased ~30-40% in all groups (all p<0.01) explained by increased glucose storage. These changes were accompanied by ~8-15% increases in VO2max, (all p<0.01), decreased fat mass and increased lean body mass in all groups (all p<0.05). There were no correlations between these training adaptations and no group-differences in these responses. HbA1c showed a clinically relevant decrease in men with type 2 diabetes (4 +/- 2 mmol/mol; p<0.05). Importantly, adherence was high (>95%) and no injuries were reported. Conclusions: A novel HIIT-protocol recruiting lower and upper body muscles efficiently improves insulin sensitivity, VO2max and body composition with intact responses in men with obesity and type 2 diabetes. The high adherence and lack of injuries show that non-weight-bearing HIIT involving several muscle groups is a promising mode of exercise training in obesity and type 2 diabetes.
... Even if regular physical activity provides an important benefit to the health of women, in general, women are often more sedentary than men (59), and participation in physical activity decreases as women age (60), increasing the risk for cardiovascular disease, diabetes, hypertension, colon cancer, and depression (61). For women with T2DM, physical activity is more important because empirical evidence shows that increasing physical activity, along with dietary changes, can dramatically decrease the risk of developing type 2 diabetes (62). However, the current evidence of sex-related differences in diet, weight, foot care, smoke and alcohol need to be improved to settle doubts coming from contradictory results. ...
Article
Full-text available
T2DM is a multifactorial disease, and it is considered a worldwide challenge for its increasing prevalence and its negative impact on patients' wellbeing. Even if it is known that self-care is a key factor in reaching optimal outcomes, and males and females implement different self-care behaviors, sex-related differences in self-care of patients with T2DM have been poorly investigated. Especially, an overall view of the available evidence has not yet been done. Accordingly, this review aims to summarize, critically review, and interpret the available evidence related to the sex-related differences in self-care behaviors of patients with T2DM. An extensive literature review was performed with a narrative synthesis following the PRISMA statement and flowchart through four databases: PubMed, CINAHL, Scopus, and Embase. From the 5776 identified records by the queries, only 29 articles were included, having a high-quality evaluation. Both females and males with T2DM must improve their self-care: more males reported performing better behaviors aimed at maintaining health and clinical stability (i.e., self-care maintenance) than females, but mainly in relation to physical activity. On the other hand, more females reported performing adequate behaviors aimed at monitoring their signs and symptoms (i.e., self-care monitoring) but with worse glycemic control and diabetic complications (i.e., self-care management). This review firstly provides an overall view of different self-care behaviors implemented by males and females with T2DM, showing that self-care management should be improved in both sexes. Health education must include the problems related to the diabetic pathology and the patient's own characteristics, such as sex.
Article
Research on risk factors for diabetes (DM) is growing. Identification of these risk factors aims to prevent DM as early as possible. This study intends to identify the utilization of the Finnish diabetes risk score (FINDRISC) and its development using bibliometric analysis. The keywords “FINDRISC AND Diabetes” were used to search for articles published in 2005-2021 in PubMed. A total of 249 articles were analyzed based on the number of publications per year, journals that publish the papers, number of publications by author and year of publication, number of publications by affiliation and year of publication, number of publications by country of origin of authors and year of publication, number of keywords, number of citations, types of articles, specific topics, and theme mapping. The data visualization was obtained from the Scopus database and the VOSviewer and Biblioshiny applications. Despite the increase in publications, the number of publications on FINDRISC in DM patients is still very few per year, with 92.8% being the primary study. Based on clusters of the country of origin, publications are still dominated by researchers from countries in the European region, and the researchers intensely relate to each other through citations. Research themes related to FINDRISC are not limited to DM risk factors. This study is the first study of a bibliometric analysis of the utilization of FINRISC in DM patients. The analysis results can be used to evaluate existing research gaps and identify future research opportunities.
Article
Full-text available
Introduction The Nepali-speaking Bhutanese (NSB) community is a rapidly growing population in Central Pennsylvania. A community-based diabetes education pilot program found a large gender disparity with fewer women in attendance; participants reported that primary household cooks and caretakers were women. This may be an indication of women’s status in the NSB community, their healthcare access, autonomy, and ability to manage their diabetes. Hence, this study aims to understand the manifestations of patriarchy and its impact on NSB women’s diabetes self-management employing a conceptual framework based on Walby’s structures of patriarchy. Methods An exploratory feminist qualitative inquiry was conducted. Fifteen NSB women with Type 2 Diabetes were interviewed about their diabetes self-management. Transcripts were coded for key concepts that emerged from the data. A thematic analysis was conducted. Themes were developed inductively through those categories as well as through an a priori approach using the conceptual framework. Results Cultural influences such as family structure, religious beliefs, traditional healthcare and gender roles determined NSB women’s patriarchal upbringing and lifestyle. Unpaid household production was largely dependent on women. Multiple immigrations led to poor socioeconomic indicators and marginalization of NSB women. Women’s access to healthcare (including diabetes) was entirely reliant on other family members due to poor autonomy. Women experienced adverse physical and emotional symptoms related to diabetes and their ability and attempts to maintain a healthy diabetes lifestyle was determined by their physical health condition, knowledge regarding good dietary practices and self-efficacy. Conclusion Patriarchal practices that start early on within women’s lives, such as child marriage, religious restrictions as well as women’s access to education and autonomy impacted NSB women’s access to healthcare, knowledge regarding their diabetes and self-efficacy. Future interventions tailored for diabetes prevention and self-management among NSB women should factor in patriarchy as an important social determinant of health.
Article
Importance: Latino youths are disproportionately impacted by prediabetes and type 2 diabetes (T2D). Lifestyle intervention is the first-line approach for preventing or delaying T2D among adults with prediabetes. Objective: To assess the efficacy of a diabetes prevention program among Latino youths aged 12 to 16 years with prediabetes. Design, setting, and participants: This 2-group parallel randomized clinical trial with 2:1 randomization assessed a lifestyle intervention against usual care among Latino youths with prediabetes and obesity with 6- and 12-month follow-up. The study was conducted at YMCA facilities in Phoenix, Arizona from May 2016 to March 2020. Intervention: Participants were randomized to lifestyle intervention (INT) or usual care control (UCC). The 6-month INT included 1 d/wk of nutrition and health education and 3 d/wk of physical activity. UCC included 2 visits with a pediatric endocrinologist and a bilingual, bicultural registered dietitian to discuss diabetes risks and healthy lifestyle changes. Main outcomes and measures: Insulin sensitivity, glucose tolerance, and weight-specific quality of life (YQOL-W) at 6- and 12-month follow-up. Results: A total of 117 Latino youths (mean [SD] age, 14 [1] years; 47 [40.1%] girls) were included in the analysis. Overall, 79 were randomized to INT and 38 to UCC. At 6 months, the INT led to significant decreases in mean (SE) 2-hour glucose (baseline: 144 [3] mg/dL; 6 months: 132 [3] mg/dL; P = .002) and increases in mean (SE) insulin sensitivity (baseline: 1.9 [0.2]; 6 months: 2.6 [0.3]; P = .001) and YQOL-W (baseline: 75 [2]; 6 months: 80 [2]; P = .006), but these changes were not significantly different from UCC (2-hour glucose: mean difference, -7.2 mg/dL; 95% CI, -19.7 to 5.3 mg/dL; P for interaction = .26; insulin sensitivity: mean difference, 0.1; 95% CI, -0.7 to 0.9; P for interaction = .79; YQOL-W: mean difference, 6.3; 95% CI, -1.1 to 13.7; P for interaction = .10, respectively). Both INT (mean [SE], -15 mg/dL [4.9]; P = .002) and UCC (mean [SE], -15 mg/dL [5.4]; P = .005) had significant 12-month reductions in 2-hour glucose that did not differ significantly from each other (mean difference, -0.3; 95% CI, -14.5 to 14.1 mg/dL; P for interaction = .97). At 12 months, changes in mean (SE) insulin sensitivity in INT (baseline: 1.9 [0.2]; 12 months: 2.3 [0.2]; P = .06) and UCC (baseline: 1.9 [0.3]; 12 months: 2.0 [0.2]; P = .70) were not significantly different (mean difference, 0.3; 95% CI, -0.4 to 1.0; P for interaction = .37). At 12 months, YQOL-W was significantly increased in INT (basline: 75 [2]; 12 months: 82 [2]; P < .001) vs UCC (mean difference, 8.5; 95% CI, 0.8 to 16.2; P for interaction = .03). Conclusions and relevance: In this randomized clinical trial, both INT and UCC led to similar changes in T2D risk factors among Latino youths with diabetes; however, YQOL-W was improved in INT compared with UCC. Diabetes prevention interventions that are effective in adults also appeared to be effective in high risk youths. Trial registration: ClinicalTrials.gov Identifier: NCT02615353.
Article
Full-text available
Background As lifestyle modification offers a unique strategy to prevent diabetes, we evaluated the effectiveness of lifestyle interventions in the prevention of type 2 diabetes and gestational diabetes in low- and middle-income countries (LMICs). Methods We did a systematic literature review and meta-analysis. We searched MEDLINE, Embase, Web of Science, and Cochrane Library for randomised controlled trials published in English, Spanish, French, and Portuguese between 1 January 2000 and 15 June 2022, evaluating multi-target and multi-component lifestyle interventions in at-risk populations conducted in LMICs. The main outcomes were incidence of type 2 diabetes and gestational diabetes, and indicators of glycaemic control. We assessed the methodological quality of the studies using the Cochrane risk of bias tool. Inverse-variance random-effects meta-analyses estimated the overall effect sizes. Sources of heterogeneity and study bias were evaluated. The study protocol was registered in PROSPERO (CRD42021279174). Findings From 14 330 abstracts, 48 (0·3%) studies with 50 interventions were eligible of which 56% were conducted in lower-middle-income countries, 44% in upper-middle, and none in low-income. 54% of the studies were assessed as moderate risk of bias and 14% as high risk. A median of 246 (IQR 137-511) individuals participated in the interventions with a median duration of 6 (3-12) months. Lifestyle interventions decreased the incidence risk ratio of type 2 diabetes by 25% (0·75 [95% CI 0·61 to 0·91]), and reduced the levels of HbA1c by 0·15% [−0·25 to −0·05], fasting plasma glucose by 3·44 mg/dL [−4·72 to −2·17], and 2-hr glucose tolerance by 4·18 mg/dL [−7·35 to −1·02]. No publication bias was suggested for these outcomes. High levels of heterogeneity (I²≥ 81%) were found in most meta-analyses. Exploration using meta-regressions could not identify any explanatory variable, except for fasting glucose for which the quality score of the articles seems to be an effect modifier decreasing slightly the heterogeneity (72%) in the low risk of bias pooled estimate. The effect on gestational diabetes could not be evaluated due to the scarcity of available studies. Interpretation Comprehensive lifestyle interventions are effective strategies to prevent type 2 diabetes among at-risk populations in LMICs. The heterogeneity identified in our results should be considered when using these interventions to address the onset of type 2 diabetes. Funding None.
Article
Full-text available
The potential role of physical activity in the primary prevention of non-insulin-dependent diabetes mellitus (NIDDM) is largely unknown. We examined the association between regular vigorous exercise and the subsequent incidence of NIDDM in a prospective cohort of 87,253 US women aged 34-59 years and free of diagnosed diabetes, cardiovascular disease, and cancer in 1980. During 8 years of follow-up, we confirmed 1303 cases of NIDDM. Women who engaged in vigorous exercise at least once per week had an age-adjusted relative risk (RR) of NIDDM of 0.67 (p less than 0.0001) compared with women who did not exercise weekly. After adjustment for body-mass index, the reduction in risk was attenuated but remained statistically significant (RR = 0.84, p = 0.005). When analysis was restricted to the first 2 years after ascertainment of physical activity level and to symptomatic NIDDM as the outcome, age-adjusted RR of those who exercised was 0.5, and age and body-mass index adjusted RR was 0.69. Among women who exercised at least once per week, there was no clear dose-response gradient according to frequency of exercise. Family history of diabetes did not modify the effect of exercise, and risk reduction with exercise was evident among both obese and nonobese women. Multivariate adjustments for age, body-mass index, family history of diabetes, and other variables did not alter the reduced risk found with exercise. Our results indicate that physical activity may be a promising approach to the primary prevention of NIDDM.
Article
Background The American Diabetes Association (ADA) recommend that fasting glucose alone with the oral glucose tolerance test should be used to diagnose diabetes mellitus. We assessed mortality associated with the ADA fasting-glucose criteria compared with the WHO 2 h post-challenge glucose criteria. Methods We assessed baseline data on glucose concentrations at fasting and 2 h after the 75 g oral glucose tolerance test from 13 prospective European cohort studies, which included 18 048 men and 7316 women aged 30 years or older. Mean follow-up was 7–3 years. We assessed the risk of death according to the different diagnostic glucose categories. Findings Compared with men who had normal fasting glucose (<6.1 mmol/L), men with newly diagnosed diabetes mellitus by the ADA fasting criteria (≤7.0 mmol/L) had a hazard ratio for death of 1.81 (95% CI1.49–2.20); for women the hazaid ratio was 1.79 (1.18–2.69). For impaired fasting glucose (6.1–6.9 mmol/L), the hazard ratios were 1.21 (1.05–1.41) and 1.08 (0.70–1.66). Fbrthe WHO criteria (≤11.1 mmol/L), the ratios for newly diagnosed diabetes were 2.02 (1.66–2.46) in men and 2.77 (1.96–3.92) in women, and for impaired glucose tolerance (7.8–11.1 mmol/L) were 1.51 (1.32–1.72) and 1.60 (1.22–2.10). Within each fasting-glucose classification, mortality increased with increasing 2 h glucose. However, for 2 h glucose classifications of impaired glucose tolerance, and diabetes, there was no trend for increasing fasting glucose concentrations. Interpretation Fasting-glucose concentrations alone do not identify individuals at increased risk of death associated with hyperglycaemia. The oral glucose tolerance test provides additional prognostic information and enables detection of individuals with impaired glucose tolerance, who have the greatest attributable risk of death
Article
In dietary studies the food composition data are needed for assessing intake of study subjects. A database for this purpose should include content for foods as consumed, i.e. the database should include brands and dishes described by recipes. The progress made in developing the national Finnish food composition database for dietary studies at the National Public Health Institute is presented. The usefulness of a relational database model in database maintenance is considered and some gaps (e.g. missing foods and retention factors for loss) are discussed. As future challenges, setting priorities in analysis needs, co-operation on food description as well as on nutrient identification are emphasized.
Article
From a previously reported 5-year screening programme of 6,956 47-49-year-old Malmö males, a series of 41 subjects with early-stage Type 2 (non-insulin-dependent) diabetes mellitus and 181 subjects with impaired glucose tolerance were selected for prospective study and to test the feasibility aspect of long-term intervention with an emphasis on life-style changes. A 5-year protocol, including an initial 6-months (randomised) pilot study, consisting of dietary treatment and/or increase of physical activity or training with annual check-ups, was completed by 90% of subjects. Body weight was reduced by 2.3-3.7% among participants, whereas values increased by 0.5-1.7% in non-intervened subjects with impaired glucose tolerance and in normal control subjects (p less than 0.0001); maximal oxygen uptake (ml.min-1.kg-1) was increased by 10-14% vs decreased by 5-9%, respectively (p less than 0.0001). Glucose tolerance was normalized in greater than 50% of subjects with impaired glucose tolerance, the accumulated incidence of diabetes was 10.6%, and more than 50% of the diabetic patients were in remission after a mean follow-up of 6 years. Blood pressure, lipids, and hyperinsulinaemia were reduced and early insulin responsiveness to glucose loading preserved. Improvement in glucose tolerance was correlated to weight reduction (r = 0.19, p less than 0.02) and increased fitness (r = 0.22, p less than 0.02). Treatment was safe, and mortality was low (in fact 33% lower than in the remainder of the cohort).(ABSTRACT TRUNCATED AT 250 WORDS)
Article
A useful paradigm for developing a public health strategy for combating chronic diseases consists of three phases: observational epidemiological studies, first cross-sectional and then prospective; intervention trials; and, finally, public health action. Although the field of cardiovascular epidemiology is well advanced into the third phase, i.e., public health action, the field of diabetes epidemiology is at least a generation behind and has only recently entered the phase of prospective observational studies. Part of the reason for this lag may be that, unlike cardiovascular disease, non-insulin-dependent (type II) diabetes has not been traditionally viewed as an epidemic, thereby detracting from a sense of urgency about the disease. Although this perspective may be appropriate for white populations, data from around the world make it increasingly apparent that type II diabetes has indeed reached epidemic proportions in non-white populations. Prospective studies are needed to firmly establish risk factors on which public health actions can be confidently based. Although anthropometric and metabolic risk factors such as obesity, body fat distribution, and circulating glucose and insulin concentrations are becoming well established as risk factors for type II diabetes, much less is known about behavioral risk factors. These latter risk factors are especially important because they are often amenable to public health action. There are preliminary data suggesting that decreased physical activity and increased fat consumption may be behavioral risk factors for diabetes. Decreased total energy intake, reflecting either low levels of physical activity or an intrinsically low metabolic rate, perhaps genetic in origin, may also be a diabetes risk factor. Unlike the field of cardiovascular epidemiology, in which there is already a critical mass of intervention trials on primary prevention, such trials are essentially nonexistent in the field of diabetes epidemiology; they are urgently needed. Although the notion of a single gene causing diabetes is clearly simplistic, there is a reasonable expectation that genetic markers can be identified that would be useful in screening for genetic susceptibles, at least in selected predisposed populations. Such markers could then be used to identify target populations for primary-prevention trials and public health action. Although primary-prevention trials should not be deferred until genetic markers are available, these two research paths may someday converge and genetic markers may come to play an important role in screening individuals as part of a comprehensive public health strategy. Numerous trial designs should be considered for testing hypotheses about the primary prevention of type II diabetes. These include single risk factor, multiple risk factor, and factorial designs.(ABSTRACT TRUNCATED AT 400 WORDS)
Article
Type 2 (non-insulin-dependent) diabetes mellitus is the major form of the disease in all societies. Its public health impact appears to be increasing and the greatest genetic predisposition to the disease is encountered in developing communities. The reduction or elimination of disease in whole populations is a fundamental goal in public health. Whilst several factors are associated with the development of Type 2 diabetes, it is not clear how they cause the disease, if indeed they do, nor whether they act in the same way in all populations. Risk factors may be true determinants of a disease but alternatively they may be associated with its occurrence only by virtue of an innocent relationship with the true causes. Furthermore, known risk factors usually explain only a small proportion of any chronic disease. The role of risk factors in disease causation is therefore of fundamental importance in considering disease prevention. Two alternative strategies for prevention of disease in populations have been proposed. The population strategy seeks to remove the causes of disease in communities as a whole, whilst the high-risk strategy aims to identify subjects at increased risk, and to intervene selectively. The population approach should be tried and carefully evaluated in selected communities at above-average risk of several noncommunicable diseases. However, certain epidemiological features of Type 2 diabetes, including the distributional characteristics of glycaemia and the complications of hyperglycaemia, the clustering of cardiovascular risk factors in the diabetic subpopulation, as well as uncertainties over the causal nature of known risk factors, suggest that a high-risk approach to prevention is also appropriate.(ABSTRACT TRUNCATED AT 250 WORDS)
Article
Impaired glucose tolerance (IGT) constitutes two-thirds of all glucose intolerance in the United States and is a major risk factor for diabetes. Despite these findings, the clinical and epidemiological significance of IGT has not been well investigated. The Second National Health and Nutrition Examination Survey, a cross-sectional study in which 75-g 2-h oral glucose tolerance tests (OGTTs) were performed, has provided an opportunity to examine the characteristics of IGT in the U.S. population. Data from the survey have been extrapolated to represent all U.S. residents. The findings indicate that approximately 11.2% of Americans aged 20-74 yr have IGT compared to 6.6% with diabetes. Rates of IGT increased with age for White men and women and Black men but declined for Black women greater than 54 yr of age, possibly because greater obesity in Black women precipitated earlier conversion of IGT to diabetes. The distribution of 2-h glucose values showed IGT to be part of a continuum of glucose intolerance extending from normal to diabetes. Individuals with IGT had rates of risk factors for non-insulin-dependent diabetes (age, plasma glucose, past obesity, family history of diabetes, physical inactivity) that were intermediate between those of individuals with normal glucose tolerance and those with diabetes, although current obesity was similar for IGT and diabetes. The proportion of people with medical histories of diabetes-related conditions did not differ between IGT and normal glucose tolerance. However, several cardiovascular findings were more prevalent in individuals with IGT than in those with normal glucose tolerance, including hypertension, serum cholesterol, angina, abnormal heart findings, and medical history of arteriosclerosis and stroke. Both obesity and reported family history of diabetes were associated with higher rates of IGT, with the effect of weight gain on the prevalence of IGT occurring at lower levels than for diabetes.