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A Small Particle Size Diet Reduces Upper Gastrointestinal Symptoms in Patients With Diabetic Gastroparesis: A Randomized Controlled Trial


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Objectives: Gastroparesis is a well-known complication to diabetes mellitus (DM). Dietary advice is considered to be of importance to reduce gastrointestinal (GI) symptoms in patients with diabetic gastroparesis, but no randomized controlled trials exist. Our aim was to compare GI symptoms in insulin treated DM subjects with gastroparesis eating a diet with small particle size ("intervention diet") with the recommended diet for DM ("control diet"). Methods: 56 subjects with insulin treated DM and gastroparesis were randomized to the intervention diet or the control diet. The patients received dietary advice by a dietitian at 7 occasions during 20 weeks. GI symptom severity, nutrient intake and glycemic control were measured before and after the intervention. Results: A significantly greater reduction of the severity of the key gastroparetic symptoms-nausea/vomiting (P=0.01), postprandial fullness (P=0.02) and bloating (P=0.006)-were seen in patients who received the intervention diet compared with the control diet, and this was also true for regurgitation/heartburn (P=0.02), but not for abdominal pain. Anxiety was reduced after the intervention diet, but not after the control diet, whereas no effect on depression or quality of life was noted in any of the groups. A higher fat intake in the intervention group was noted, but otherwise no differences in body weight, HbA1c or nutrient intake were seen. Conclusions: A small particle diet improves the key symptoms of gastroparesis in patients with diabetes mellitus. ( NCT01557296).
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© 2014 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY
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Gastroparesis is de ned as delayed gastric emptying in the absence
of an obstruction to out ow from the stomach ( 1 ), and is a well-
known complication to diabetes mellitus (DM) and occur in both
DM type1 and 2 ( 2,3 ). Diabetic gastroparesis is o en associated
with at least one of following factors: gastrointestinal (GI) symp-
toms, nutrition di culties and / or poor glycemic control including
postprandial hypoglycemia ( 3,4 ).  e prevalence of gastroparesis
in patients with DM is uncertain, but is suggested to be present
in 30 65 % of outpatients with long standing DM ( 2,3 ). In clinical
practice, the presence of gastroparesis is o en under-recognized,
and therefore its clinical consequences are sometimes not man-
aged in an optimal manner ( 5 ).  e pathogenesis of this disabling
condition is probably complex and still not well understood
( 6 ), but it is associated with the presence of diabetic autonomic
neuropathy ( 7 ).
In patients with diabetic gastroparesis it is of importance to opti-
mize the metabolic control, because hyperglycemia per se inhibit
gastric emptying, which may further deteriorate glycemic con-
trol ( 8 ). Coordination of exogenous insulin action with nutrient
delivery to intestine is crucial, as poor coordination may lead to
unstable plasma glucose levels, hyperglycemia and hypoglycemia,
which may result in poor glycemic control ( 9 ). In patients with
delayed gastric emptying the coordination of insulin and nutrient
A Small Particle Size Diet Reduces Upper
Gastrointestinal Symptoms in Patients With Diabetic
Gastroparesis: A Randomized Controlled Trial
Eva A . Olausson , RD, PhD
1 , Stine St ö rsrud , RD, PhD
1 , H å kan Grundin , Ph Mag
2 , Mats Isaksson , PhD
2 , Stig Attvall , MD, PhD
1 and
Magnus Simr é n , MD, PhD
OBJECTIVES: Gastroparesis is a well-known complication to diabetes mellitus (DM). Dietary advice is considered
to be of importance to reduce gastrointestinal (GI) symptoms in patients with diabetic gastroparesis,
but no randomized controlled trials exist. Our aim was to compare GI symptoms in insulin treated
DM subjects with gastroparesis eating a diet with small particle size ( intervention diet ) with the
recommended diet for DM ( control diet ).
METHODS: 56 subjects with insulin treated DM and gastroparesis were randomized to the intervention diet or
the control diet. The patients received dietary advice by a dietitian at 7 occasions during 20 weeks.
GI symptom severity, nutrient intake and glycemic control were measured before and after the inter-
RESULTS: A signifi cantly greater reduction of the severity of the key gastroparetic symptoms nausea / vomiting
( P = 0.01), postprandial fullness ( P = 0.02) and bloating ( P = 0.006) were seen in patients who
received the intervention diet compared with the control diet, and this was also true for regurgitation /
heartburn ( P = 0.02), but not for abdominal pain. Anxiety was reduced after the intervention diet, but
not after the control diet, whereas no effect on depression or quality of life was noted in any of the
groups. A higher fat intake in the intervention group was noted, but otherwise no differences in body
weight, HbA1c or nutrient intake were seen.
CONCLUSIONS: A small particle diet improves the key symptoms of gastroparesis in patients with diabetes mellitus.
( NCT01557296)
Am J Gastroenterol advance online publication, 14 January 2014; doi: 10.1038/ajg.2013.453
1 Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska, Academy, University of Gothenburg , Gothenburg , Sweden ;
2 Department of Radiation Physics, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden . Correspondence:
Magnus Simr é n, MD, PhD , Department of Internal Medicine & Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg , 41345
Gothenburg , Sweden . E-mail:
Received 15 August 2013; accepted 19 November 2013
The American Journal of GASTROENTEROLOGY VOLUME 104 | XXX 2012
Olausson et al.
delivery to the small intestine is problematic. Based on the well-
known importance of achieving a good metabolic control to pre-
vent diabetic complications ( 10 ), improving the predictability of
this coordination seems important.
Patients with diabetic gastroparesis o en su er from a wide
array of predominantly, but not exclusively, upper GI symptoms.
Of these, abdominal pain ( 11 ), bloating ( 2 ), postprandial fullness
( 2,12 ), early satiety, nausea and vomiting ( 11 ) occur most fre-
quently.  e presence of these symptoms contributes to the fact
that many patients with gastroparesis have diets de cient in calo-
ries, vitamins, and minerals ( 8,13 ).  e combination of severe GI
symptom, poor metabolic control and nutritional di culties also
impairs the quality of life in these patients ( 14 ). Moreover, patients
with diabetic gastroparesis have been found to require more
healthcare than other groups of patients with DM ( 15 ).
e management of patients with diabetic gastroparesis includes
attempts to improve gastric emptying, relieve GI symptoms, and
improve glycemic control and the nutritional state.  e pharma-
cologic treatment options include mainly the use of prokinetic and
antiemetic drugs.  e rst choice of treatment in patients with dia-
betic gastroparesis is most o en dietary advice. However, to the
best of our knowledge there are no randomized controlled trials
assessing the e ect of dietary interventions in diabetic gastropare-
sis. Current dietary recommendations for patients with gas-
troparesis include suggestions derived from an empirical approach
that compensate for the impairment of gastric emptying by con-
suming foods that are low in fat and  ber, as it is well established
that these nutrients delay gastric emptying ( 16 ). To maintain the
energy intake at an acceptable level the recommendation suggests
small, frequent meals ( 17,18 ). In a previous study we compared
the gastric emptying rate with two di erent meals based on the
same caloric content and food composition, but with di erences
in particle size between the meals.  e gastric emptying rate of a
meal with large particle size was clearly di erent between patients
with diabetic gastroparesis and healthy control subjects, whereas
the emptying rate of a meal with small particle size was more simi-
lar (no signi cant di erence) between subjects with diabetes and
gastroparesis and healthy subjects ( 19 ).
erefore, the aim of this study was to compare the e ects of a die-
tary intervention recommending meals with small particle size with
the standard dietary recommendations to patients with DM ( 20 ),
in insulin treated diabetic subjects with gastroparesis. Our primary
goal was to improve GI symptoms associated with gastroparesis,
and the secondary goal to assess e ects on body weight, nutritional
intake, metabolic control, mental health and quality of life.
For participation in this 20-weeks parallel group, dietary interven-
tion trial, we evaluated patients with insulin treated DM between
18 and 70 years, and with a clinical suspicion of gastroparesis,
based on the presence of upper GI symptoms and / or unsta-
ble plasma glucose. In order to be included, the patients had to
demonstrate delayed gastric scintigraphic emptying (see below),
and no evidence of mechanical obstruction, i.e. ful lling the de -
nition of gastroparesis.  e subject should be able to understand
verbal and written information and complete questionnaires in
Swedish. Exclusion criteria were: previous GI surgery except
appendectomy, severe psychiatric disease, sequelae a er cerebrov-
ascular disease, serum creatinine > 150 μ mol / l, and untreated dis-
ease with a potential impact on gastric emptying or GI symptoms.
In order to exclude mechanical obstruction or another GI expla-
nation behind the upper GI symptoms, all patients had to have
been investigated with upper GI endoscopy within one year prior
to inclusion in the study. Clinical characteristics of the subjects
were obtained from chart review.
is study was approved by the Regional Ethical Review Board
at the University of Gothenburg, Gothenburg, Sweden. Each par-
ticipant was verbally informed about the study and was given writ-
ten information, and prior to any study related procedure they
gave written informed consent.
Gastric scintigraphy
e gastric emptying rate was measured with gastric scintigraphy
according to a nationwide standard method ( 21,22 ). Reference
values for solid gastric emptying have been established in a study
of 160 healthy subjects (69 males, 91 females), and for men the
normal range for retention of the radioactivity in the stomach at
120 min a er the  nished meal (R
120 ) is 0 – 51 % , for women < 50
years old, 9 – 66 % , and for women > 50 years old 0 – 55 % ( 22 ). As
hyperglycemia per se delays gastric emptying ( 23 ), plasma glucose
at the beginning of the gastric scintigraphy had to be 10 mmol / l.
Severity of GI symptoms. e subjects were asked to complete
the validated questionnaire, Patient Assessment of Gastrointesti-
nal Disorders-Symptom Severity Index (PAGI-SYM) to assess GI
symptom severity during the preceding 2 weeks ( 24 ).  e 20-item
PAGI-SYM includes 6 subscales: nausea / vomiting, fullness / early
satiety, bloating, upper abdominal pain, lower abdominal pain
and heartburn / regurgitation analyzed on a 6-point Likert scale
ranging from 0 (no symptoms), 1 (very mild), 2 (mild), 3 (moder-
ate), 4 (severe) to 5 (very severe symptoms).  is instrument has
undergone thorough validation procedures and has been found
to be construct valid, reliable and responsive to changes in pa-
tients with upper GI disorders ( 25 ) and has been found to be con-
struct valid and reliable in gastroparesis ( 24 ). Furthermore, a sub-
set of this scale, the nine-item Gastroparesis Cardinal Symptom
Index (GCSI) consisting of the three subscales nausea / vomiting,
fullness / early satiety and bloating, has been validated in patients
with gastroparesis ( 26,27 ).
Anxiety and depression. e severity of anxiety and depression
were determined with the self-reporting questionnaire, Hospital
Anxiety and Depression Scale (HADS) ( 28 ).  e HADS contains
14 items, 7 items on depression and 7 items on anxiety. Patients
score to the extend they agree with each statement on a 4-point
scale, ranging from 0 to 3. Cut o points for severity in each do-
main are scores: 0 – 7 = normal; 8 – 10 = mild; 11 – 14 = moderate;
© 2014 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY
A Small Particle Size Diet in Diabetic Gastroparesis
and 15 – 21 = severe. A score of 8 or above is considered abnormal.
e HADS questionnaire has been reported to have good valid-
ity in diabetic subjects ( 29 ). Factor structure, discriminant validity
and internal consistency were studied in a review paper, and the
authors found that the sensitivity and speci city for detecting
anxiety and depression were 0.80 ( 30 ).
Quality of life. e quality of life was determined with the widely used
generic questionnaire the 36-item Short-Form Health Survey (SF-36)
( 31,32 ). e Swedish translation has also been thoroughly validated
( 33 ). SF-36 consists of eight di erent domains, and these can be sum-
marized in a physical component summary (PCS): physical function-
ing, role physical, bodily pain and general health; and a mental com-
ponent summary (MCS): vitality, social functioning, role emotional
and mental health.  e highest possible score is 100, where no limita-
tions or disabilities are reported, and the lowest score possible is zero,
where the greatest degree of limitation or disability is reported.
Dietary intake, nutrition and glycemic control
A dietitian (EO) trained all the subjects in completing a 4-day
food diary at home. Dietary recordings were performed during
one day during the weekend and 3 days during weekdays.  e
amount of all food and beverages were recorded in weight and
household measures.  e dietitian interviewed each subject and
any ambiguities were resolved upon return of the food records.
e same dietitian calculated the nutrient content in all dietary
records from the Database Swedish National Food Composition
Tables, 11th of April 2007 (National Food Agency, Uppsala, Swe-
den) using the computer program Dietist XP version 3.2, (Diet
and Nutrition Data, Bromma, Sweden). For this study, the caloric
content (kcal), and the amount of protein, fat, carbohydrates and
ber (all in grams) were used.
Body weight was recorded in underwear clothing and without
shoes to the nearest 0.1 kg on calibrated, electronic scales (Serial
no 11087, system 31, Advanced weighing Co Ltd, New Haven, East
Sussex, BN9 0DU, UK). Height was measured in standing position
to the nearest 0.5 cm. Body mass index (BMI) was calculated as
weight (kg) divided by height squared (m
2 ) (kg / m 2 ).
Blood samples were collected for the analyses of glycosylated
hemoglobin (HbA1c).  e analyses were conducted at an
accredited reference laboratory (Clinical Chemistry laboratory,
Sahlgrenska University Hospital, Gothenburg, Sweden) accord-
ing to the ISO / IEC 15 189 Standard for Medical Laboratories.
HbA1c were converted to the Diabetes Control and Complica-
tions Trial (DCCT), standard levels using the formula: HbA1c
(DCCT) = (0.923 × HbA1c (MonoS) + 1.345; R 2 = 0.998) ( 34 ).
Study design
Subjects with insulin treated DM and suspected gastroparesis
were asked if they were willing to participate in this study. If a
diagnosis of diabetic gastroparesis was con rmed with scintig-
raphy, and the patient agreed to participate in the study, he / she
was further evaluated at the randomization visit where a dietitian
(EO) instructed the subject how to complete the questionnaires;
PAGI-SYM, HADS and SF36 and how to complete 4-days dietary
food record the food record was completed at home, the other
questionnaires were completed at the hospital at baseline. At the
same occasion body weight, height and a blood sample for the
analysis of HbA1c were taken. If the patient met all the inclusion
criteria, and had no exclusion criteria, he / she was randomized
to one of the two dietary treatment groups (see below) by draw-
ing envelopes. Moreover, the patient was also randomized to be
treated by one of two dietitians (EO or SS). During the study, each
patient received dietary advice from the same dietitian at seven
outpatient visits (each lasting approximately 45 60 min) during
20 weeks. Both dietitians followed the same written instructions
on how to give dietary advice to the patients in the two treatment
groups (see Appendices ). e time interval between the  rst three
visits was 2 weeks, between visits 4 7 the interval was 3 weeks,
and the  nal visit (visit 8) occurred 4 weeks a er visit 7, i.e. 20
weeks a er the randomization visit.
Before the  nal visit, the patients had completed the ques-
tionnaires PAGI-SYM, HADS, SF36 and a 4-days dietary record
at home, and these were collected by one dietitian (EO). At this
visit the body weight, height, gastric emptying and blood sample,
HbA1c, were measured again.
e patients were randomized to receive dietary advice, which
di ered regarding the particle size of the food (for more detailed
information, see Appendices ). Otherwise the nutritional compo-
sition in the two dietary treatment groups was the same. Except
recommending the fat content to be reduced to 25 30 % of total
energy and the  ber content to 15 gram / 1,000 kcal, in order to
be in line with the earlier study ( 19 ) and with the current rec-
ommendations for patients with gastroparesis ( 16 ), the diet was
in accordance with the recommended diet in diabetes ( 20 ). Both
groups were advised to have the same meal scheme; breakfast,
snack, lunch, snack, dinner and evening snack, and received die-
tary counseling on 7 occasions.
Intervention diet. is group received advice to eat foods with
small particle size or food items that could easily be processed into
small particle size ( Appendix 1 ). A characteristic feature of the in-
tervention diet was that the food should be easy to mash with a
fork into small particle size, e.g. mealy potatoes .  erefore, this
diet excludes foods with the following characteristics: foods with
husks / peels (e.g. corn, peas, tomato, sprouts, onions, cabbage),
membranes (e.g. orange, lemons and grapefruit), stringy foods
(e.g. rhubarb, asparagus, leeks, stalks of broccoli and cauli ower),
seeds and grains (e.g. nuts and almonds, bread with whole grains),
compact, poorly digestible particles (such as pasta, rice, grated veg-
etables, meat, raw vegetable salad and cheese slices) and white fresh
bread. However, if e.g. corn, peas and onion have been mixed in a
food processor to a similar consistency as mashed potato, these
were allowed in the intervention diet, and food items like almonds
and nuts could be included if they had been ground into  our.
Control diet. is group received advice to eat the food usually
recommended for patients with diabetes ( 20 ), and allowed foods
The American Journal of GASTROENTEROLOGY VOLUME 104 | XXX 2012
Olausson et al.
with large particle size and the food items should have a low
glycemic index ( 35 ) ( Appendix 2 ). Examples of food items with
large particle size are whole meat, seafood, cheese slices, almonds
and nuts. Examples of foods with low glycemic index are pasta,
rice, grated vegetables, raw vegetable salad, wok vegetables, fresh
fruit and bread with whole grain and / or sourdough.  is diet
does not contain foods with small particle size, e.g. milkshakes,
berry and fruit compote, mashed potato, smooth soups and
mashed turnips.
Data analysis and statistics
e patients were randomized into two groups, one who received
advice to eat the intervention diet with food with small particle
size, and a group who were advised to eat the control diet, i.e. the
diet with large particle size and similar to the standard diet recom-
mended for diabetes, but adapted for patients with gastroparesis.
ese two groups were then used for within- and between-group
comparisons. SPSS version 18.0 for Windows (SPSS, Inc.,
Chicago, IL) was used for statistical analyses. We performed the
analyses on an intention-to-treat population, i.e. all patients who
were randomized were included in the analyses. In case of pre-
mature drop-out, missing data were imputed from the previous
assessment using the last observation carried forward technique,
and included in the analysis.  e changes at the last visit relative to
baseline in the three PAGI-SYM subscales that constitute the Gas-
troparesis Cardinal Symptom Index (GCSI), i.e. nausea / vomiting,
fullness / early satiety and bloating, were our primary outcome
variables (between-groups comparisons), as these are considered
to be the key GI symptoms of gastroparesis. Changes in the other
PAGI-SYM domains, gastric emptying ( % retention at 120 min),
quality of life (SF-36), psychological symptom severity (HADS),
body weight, nutritional intake and glycemic control (HbA1c)
were secondary outcome variables. A sample size calculation
was performed, and in order to be able to detect a di erence in
the change of our primary outcome variables of 0.8 between the
treatment groups with 80 % power at α = 0.05, assuming a SD of 1,
at least 50 subjects with evaluable data were needed. Besides the
between-group comparisons of changes in the outcome variables,
we also performed within-group comparisons of the same varia-
bles. Moreover the associations between gastric emptying data and
change in symptoms were measured in the two treatment groups.
e demographic characteristics of the patients are presented
as mean ± s.d. and median (range), and were compared between
the groups using the Mann-Whitney U test.  e outcome vari-
ables at baseline and a er the treatment period in the two groups
are shown as mean ± s.d. and for the majority of parameters
also as median (range). For comparisons within the groups the
Wilcoxon Signed Rank test was used, whereas comparisons
between the groups for outcome variables were made using
Analysis of Covariance (ANCOVA) adjusting for baseline val-
ues. Correlations were measured using Spearman s rank correla-
tion coe cients.  e between-group di erences in changes in the
outcome variables are shown as mean and 95 % CI. Two-tailed
P values < 0.05 were accepted as statistically signi cant. No correc-
tions for multiple comparisons were performed.
Diabetic patients with insulin treated diabetes and delayed gastric
emptying were recruited from hospital and primary care outpa-
tient clinics in the western region of Sweden during the period
of August 2007-August 2011. Eighty-three diabetic subjects with
insulin treated diabetes and suspected gastroparesis were asked to
participate in the study ( Figure 1 ). Eleven of these were not willing
to take part, leaving 72 subjects who were willing to be screened
for eligibility and to be investigated with gastric scintigraphy.
Normal gastric emptying was found in 14 subjects, and 2 patients
with gastroparesis declined to take part in the dietary interven-
tion part, leaving 56 subjects (36 women) who were randomized
to the treatment groups.  irty-six of the randomized patients
had diabetes type 1 (22 intervention diet, 14 control, diet), eight-
een subjects had diabetes type 2 (5 intervention diet, 13 control
diet), one subject had Latent Autoimmune Diabetes in the Adult
(LADA) diabetes (intervention diet) and one subject had Maturity
Onset Diabetes in Young (MODY) diabetes (control diet), with a
signi cant di erence in the distribution of diabetes type 1 and 2
between the diet groups ( P = 0.02). Only one patient used a proki-
netic agent during the study, and the dose was unchanged. Demo-
graphic and clinical characteristics of the randomized patients are
presented in Table 1 , and no signi cant di erences between the
groups in any of these variables were detected.
During the treatment phase, one patient died of myocardial inf-
arction in the intervention group in the 20th week of the study,
and  ve patients ended prematurely in the control group because
of worsening of existing upper GI symptoms ( n = 3), occurrence of
new GI symptoms ( n = 1 ; a er a visit to Africa) or without any spe-
ci c reason mentioned ( n = 1). ese missing data were imputed
from the previous assessment (baseline), using the last observa-
tion carried forward technique, and included in the analysis. All
patients who completed the trial expressed adherence with dietary
treatment (verbal reports as well as food diaries) and considered
the dietary changes to be feasible.
Gastrointestinal symptoms, anxiety, depression and quality of
All GI symptoms, except for upper abdominal pain, improved
signi cantly (lower PAGI-SYM scores) a er the intervention diet
( Figure 2a ), whereas none of the GI symptoms improved a er
the control diet ( Figure 2b ). e severity of the primary outcome
variables were all signi cantly more improved a er the inter-
vention diet than a er the control diet; nausea / vomiting ( 0.56
( 1.01 to 0.11) (mean change di erence (95 % CI); P = 0.01),
fullness / early satiety ( 0.61 ( 1.14 to 0.08); P = 0.02) and
bloating ( 0.86 ( 1.48 to 0.25); P = 0.006). Also regurgitation /
heartburn was more improved a er the intervention diet than
a er the control diet ( 0.51 ( 0.94 to 0.07); P = 0.02), whereas
no group di erences were noted for upper ( 0.36 ( 1.01 – 0.28);
P = 0.27) or lower abdominal pain ( 0.50 ( 1.15 – 0.14); P = 0.12).
e change in symptom severity did not di er between patients
with diabetes type 1 and 2 in any of the groups ( P = 0.37 – 0.95 for
the primary outcome variables).
© 2014 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY
A Small Particle Size Diet in Diabetic Gastroparesis
total intake of calories,  ber, carbohydrates and protein remained
unchanged in both groups without any between-group di er-
ences. No major group di erences were noted for dietary patterns
or balance between intakes during meals or snacks (food diaries
and verbal reports). No di erences were seen between or within
the groups regarding body weight or metabolic control (HbA1c).
In both groups, gastric emptying ( % retention at 120 min) was
improved a er the treatment period relative to baseline, and this
change was signi cantly greater in the intervention group com-
pared with the control group ( Tab l e 2 ). However, the change in
gastric emptying rate at follow-up was not signi cantly associated
with the change in symptom severity measured by PAGI-SYM
(data not shown). Gastric emptying rate at baseline in the inter-
vention group tended to be negatively associated with the change
in symptoms a er treatment, which reached statistical signi cance
e severity of anxiety (HADS) was reduced in the intervention
diet group, but not in the control diet group a er the treatment
period. However, the between-group comparison of change in
anxiety score was not signi cant ( Table 2 ). Depression (HADS)
and quality of life (mental and physical component summary of
SF-36) remained unchanged in both groups and no between-group
di erences were noted ( Ta bl e 2 ).
Dietary intake, nutrition, gastric emptying and glycemic
e intake of fat changed signi cantly more in the intervention
group than in the control group, with a greater increase in the
intervention group at study completion ( Table 2 ). e fat intake
increased signi cantly in the intervention diet group, but not in
the control diet group, whereas within-group comparisons for
83 asked to participate in the study
11 not willing
to participate
2 with gastroparesis,
not willing to particpate
72 screened
14 normal gastric
56 randomized
28 control
5 drop-outs
28 intervention
1 death (MI)
27 completed the study
28 included in final analyses
23 completed the study
28 included in final analyses
Figure 1 . Flow chart demonstrating the number of patients in the different phases of the study.
Table 1 . Demographic and clinical characteristics of subjects with insulin-treated diabetes and gastroparesis presented as mean ± s.d. and
median (range)
Age, years
Duration of
Insulin / kg
weight, U Body weight, kg BMI, kg / m
μ mol / l
GFR, ml /
min / 1.73 m
, % R
, %
diet, n =28
51.5 ± 11.7 28.2 ± 14.8 23.7 ± 15.8 0.6 ± 0.3 77.9 ± 16.0 25.6 ± 4.7 82.2 ± 20.5 80.0 ± 18.8 77.1 ± 9.8 57.8 ± ± 16.4
51 (31 69) 28.0
(2.0 65.0)
28 (4 46) 0.5
(0.3 1.7)
(52.3 110.3)
(20.1 40.9)
(55 138)
(40 126)
(53 91)
(18 81)
diet, n =28
55.0 ± 11.4 23.6 ± 15.6
21.6 ± 17.4 0.7 ± 0.5 78.4 ± 15.8 27.7 ± 4.9 72.2 ± 12.3 82.7 ± 19.2 74.7 ± 12.9 59.9 ± 19.75
(27 69)
(2.0 64.0)
16 (1 63) 0.5
(0.2 2.2)
(54.6 114.4)
(18.4 36.0)
(54 100)
86 (48 128) 72.5
(55 94)
(31 91)
GFR, glomerular fi ltration rate; R
120 , retention of the radioactivity in the stomach 120 min after meal intake (gastric scintigraphy); R
180 =Retention of the radioactivity in the
stomach 180 min after meal intake (gastric scintigraphy).
The American Journal of GASTROENTEROLOGY VOLUME 104 | XXX 2012
Olausson et al.
only for upper abdominal pain (rho = 0.39; P = 0.04), i.e. patients
with greater symptom improvement tended to have less severely
a ected gastric emptying at baseline, whereas no such associations
were noted in the control group (data not shown).
In the present study we have demonstrated in a randomized con-
trolled trial that a small particle size diet substantially improved
the upper GI symptoms considered to be the key symptoms
of gastroparesis — nausea / vomiting, postprandial fullness, early
satiety and bloating ( 2,6 ) in patients with diabetic gastroparesis.
Moreover, there was also an e ect of this intervention diet on
other GI symptoms, but no major e ect could be detected on
nutrient intake or glycemic control a er 20 weeks on the small
particle diet relative to a diet normally recommended to patients
with DM.
Patients with diabetic gastroparesis o en complain of severe
upper GI symptoms and poor glycemic control. Moreover, the
severity of the upper GI symptoms is associated with reduced
quality of life ( 36 ), and may lead to inadequate nutrient intake
( 8,13 ). e treatment options are limited, but dietary modi ca-
tions are considered to be of great importance, despite the fact that
no randomized controlled trials exist.  erefore, our study is of
clinical importance, as we were able to demonstrate that advising
patients with diabetic gastroparesis to eat a diet with small particle
size signi cantly improved upper GI symptoms, whereas no such
e ect was seen when patients were advised to eat a diet normally
recommended to patients with DM, modi ed based on dietary
recommendations for gastroparesis.
Traditionally, patients with gastroparesis are recommended to
eat small, low-fat, low- ber meals 4 5 times per day ( 16 ), based
on the fact that meal volume, and the content of calories, fat and
bre a ects gastric emptying ( 19,37 ). However, in a recently pub-
lished small experimental study, we demonstrated that a solid
meal with small particle size increased the gastric emptying rate in
patients with diabetic gastroparesis ( 19 ). Based on this  nding, we
hypothesized that a diet with small particle size would improve GI
symptoms in diabetic gastroparesis, as GI symptom severity is
associated with the degree of gastric emptying, albeit modestly
( 21 ). is hypothesis could be con rmed in the present study,
which should have implications for dietary advice to patients with
diabetic gastroparesis in clinical practice.
e proximal stomach serves as reservoir for food and the
distal stomach as the grinder. A er food ingestion there is a neu-
rally mediated relaxation of the proximal stomach and when
the food enters the stomach the process of accommodation is
enhanced, which allows ingestion of food without generation of
discomfort ( 38 ). Solids are initially retained in the stomach and
undergo churning, while antral contractions propel particles
towards the closed pylorus. Food particles are emptied once their
size have been reduced to approximately 2 mm in diameter ( 37 ).
erefore, we focused our attention on food particle size when
we developed the intervention diet tested in this trial. Moreover,
as phase III of the migrating motor complex is of importance for
gastric emptying of larger particles ( 39 ), and absence of phase
III has been associated with gastroparesis, food items with large
particle size were excluded from the intervention diet ( 40 ).
erefore, based on physiology and pathophysiology of diabetic
gastroparesis, reducing particle size of the diet seems logical.
In our previous study we also demonstrated that a small par-
ticle size diet increased the late postprandial glycemic response
and reduced the postprandial blood glucose dip in patients with
diabetic gastroparesis ( 19 ).  erefore, we also hypothesized that
treatment with a small particle size diet would improve the meta-
bolic control in patients with DM and gastroparesis. However, this
was not con rmed in the present study. A potential explanation for
this may be that the study duration of 20 weeks was not su cient
to alter the metabolic control.  erefore, studies of longer duration
are needed to further evaluate the e ect of this diet on long-term
glycemic control. Moreover, no major e ect on dietary intake was
noted, nor on body weight, except for a tendency toward higher fat
*** *
N/V Fullness Bloating U abd pain L abd pain H/R
Baseline Follow-up
PAGI-SYM scores
N/V Fullness Bloating U abd pain L abd pain H/R
Baseline Follow-up
PAGI-SYM scores
Figure 2 . GI symptom severity, as measured with PAGI-SYM, at base-
line and after the dietary treatment period (20 weeks) in the group who
received advice to eat the intervention diet (small particle size) ( a ) and
the group who were instructed to follow the control diet ( b ). The between-
group comparisons demonstrated signifi cantly greater symptom improve-
ment in the intervention diet group than in the control group for the primary
outcome variables, nausea / vomiting ( P = 0.01) , fullness / early satiety
( P = 0.02) and bloating ( P = 0.006), and also for heartburn / regurgitation
( P = 0.02). * P < 0.05, * * P < 0.01, * * * P < 0.001 vs. baseline within-group
comparisons. PAGI-SYM domains: N / V, nausea / vomiting; Fullness,
fullness / early satiety; U / L abd pain , Upper / Lower Abdominal Pain;
H / R, Heartburn / regurgitation.
© 2014 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY
A Small Particle Size Diet in Diabetic Gastroparesis
In patients with diabetes, the presence of GI symptoms is asso-
ciated with psychological distress and reduced quality of life
( 41,42 ). Improvement of GI symptoms in patients with diabetic
intake in the intervention group. Again, the study duration may
have been too short for subjects to change their diet substantially
to increase nutrient intake and weight.
Table 2 . Variable at baseline and at fi nished 20 weeks study period grouped in intervention and control group, mean ± s.d., median (range)
Intervention diet, n =28 Diabetes diet, n =28
Base line
mean ±
s.d. median
Finished study
mean ± s.d.
median (range)
Change mean ±
s.d. median
(range) P value
Base line
mean ± s.d.
median (range)
study mean ±
s.d. median
Change mean ±
s.d. median
P value
I / D diet
change mean,
95 % CI
Body weight,
78.4 ± 16.3 77.9 ± 16.0 0.5 ± 3.6 NS 79.0 ± 15.6 78.5 ± 15.8
0.5 ± 2.2 NS 0.99 0.012
( 1.6 to 1.6)
(54 to 112.4)
(52.3 to 110.3)
( 13.9 to 3.9)
(54.5 to 111.0)
(54.6 to
( 5.0 to 3.8)
kcal 1,505 ± 462 1,585 ± 483.1 80 ± 385.0 NS 1,551 ± 423.1 1,454 ± 319 97 ± 417.9 NS 0.096 154 (28 to 336)
(840 to 2,893)
(771 to 3,058)
( 555 to 921)
(897 to 2,893)
(708 to 2,153)
( 1392 to 488)
Protein, g 65 ± 21.7 67 ± 17.9 1 ± 23.6 NS 69 ± 19.6 65 ± 14.0 5 ± 20.9 NS 0.38 5 ( 6 to 15)
(33 to 127)
65 (41 to 118) 0
( 63 to 55)
66 (39 to 127) 65 (39 to 92) 4
( 83 to 25)
Fat, g 60 ± 25.8 67 ± 27.6 7 ± 21.9 NS 62 ± 23.9 57 ± 13.1 5 ± 22.6 NS 0.034 11 (1 to 20)
(31 to 142)
62 (28 to 162)
( 58 to 49)
58 (29 to 142) 55 (27 to 82) 0
( 70 to 24)
drate, g
163 ± 48.9 166 ± 51.0 3 ± 48.3 NS 162 ± 44.8 149 ± 47.7 13 ± 50.0 NS 0.17 16 ( 7 to 40)
(78 to 269)
166 (79 to 268) 3
( 86 to 113)
153 (83 to 278) 141
(64 to 253)
( 134 to 69)
Fiber, g 17 ± 6.3 16 ± 5.5 1 ± 6.7 NS 17 ± 6.2 17 ±
7.5 0 ± 6.0 NS 0.53 1 ( 4 to 2)
15 (7 to 34) 15 (9 to 33) 1
( 21 to 11)
18 (7 to 33) 16 (7 to 38) 0
( 13 to 12)
HbA1c, % 7.4 ± 0.8 7.4 ± 0.8 0.0 ± 0.5 NS 7.9 ± 1.2 7.8 ± 1.1 0.2 ± 0.6 NS 0.98 0.0
( 0.3 to 0.3)
(5.6 to 9.2)
7.3 (5.2 to
( 1.2 to 0.9)
8.1 (5.4 to 9.8) 7.9
(5.7 to 10.5)
( 1.3 to 0.7)
HADS, anxiety 7.8 ± 4.3 S 6.5 ± 4.7 1.3 ± 2.7 0.024 7.2 ± 4.6 6.4 ± 4.4 0.8 ± 3.4 NS 0.63 0.4
8.0 (0 to 18) 6.0 (0 to 21) 2.0
( 5.0 to 4.0)
7.0 (1 to 17) 6.5 (1 to 21) 0.0
( 10.0 to 5.0)
6.3 ± 4.9 5.6 ± 5.4 0.6 ± 2.5 NS 6.6 ± 4.6 5.9 ± 4.8 0.7 ± 4.2 NS
0.99 0.0
( 1.8 to 1.8)
4.5 (0 17) 3.5 (0 21) 0.5
( 8.0 to 4.0)
5.0 (1 to 19) 5.0 (0 to 21) 0.0
( 12.0 to 8.0)
SF-36: PCS 39.0 ± 11.4 40.2 ± 10.9 1.2 ± 8.0 NS 37.6 ± 12.0 35.5 ± 12.8 2.1 ± 9.2 NS 0.11 3.6 ( 0.8 to 8.0)
(7.4 to 55.3)
(19.4 to 59.5)
( 18.3 to 20.3)
(13.1 to 55.3)
(8.7 to 55.5)
( 21.9 to 16.7)
SF-36: MCS 41.5 ± 15.9 43.8 ± 15.2 2.3 ± 15.0 NS 42.1 ± 13.3 41.5 ± 14.8 0.5 ± 10.9 NS 0.48 2.6 ( 3.8 to 9.0)
(10.5 to 71.0)
(9.7 to 62.2)
( 50.4 to 26.6)
(7.5 to 56.6)
(8.9 to 66.1)
( 32.0 to 20.4
retention at
2 h ( % )
77.1 ± 9.8 61.2 ± 14.5 15.3 ± 14.4 < 0.0001 74.7 ± 12.9 69.5 ± 14.5 5.2 ± 8.1 0.02 0.002 9.4 (3.7 to 15.0)
(53 to 91)
64 (36 to 87) 17
( 10 to 44)
72.5 (55 to 94) 69.0
(41 to 93)
( 6 to 26)
BMI, body mass index; HbA1c, glycosylated hemoglobin; HADS, Hospital Anxiety and Depression Scale; NS, nonsignifi cant; PAGI-SYM, Patient Assessment Of Upper
Gastrointestinal Symptom Severity Index; SF-36, the Short-Form Health Status Survey; PCS, physical component summary; MCS, mental component summary.
The variables change within the group and between the groups; mean, 95 % confi dence interval. P < 0.05.
The American Journal of GASTROENTEROLOGY VOLUME 104 | XXX 2012
Olausson et al.
gastroparesis therefore has the potential to reduce psychological
distress and improve quality of life. However, in our trial only a sig-
ni cant positive within-group e ect on anxiety in the group with
the small particle size diet was observed, but with no signi cant
between-group di erences. Moreover no e ects on depression or
quality of life measures were noted in any of the groups. Quality
of life in patients with DM is complex and certainly in uenced
by several factors ( 43 ), and so is probably psychological distress.
In our group of patients with diabetic gastroparesis, not only GI
symptoms severity has the potential to negatively in uence quality
of life, as diabetic gastroparesis is associated with other late dia-
betic complications ( 44 ).  erefore, it may not be surprising that
we failed to  nd a major e ect on psychological distress or quality
of life with our dietary intervention.  e duration of the study may
also be too short to fully appreciate the e ect of a dietary change on
general well-being. Moreover, our study was powered to detect an
e ect on upper GI symptoms, and not on these measures. Future
studies with longer duration and larger sample size may be needed
in order to fully address the e ect of this dietary intervention on
quality of life and psychological distress.
ere are of course limitations with our study.  e duration of
the study was 20 weeks, which for some of the parameters meas-
ured may be too short. Moreover, stratifying patients based on
their gastric emptying response to a small particle meal at base-
line could theoretically have enhanced our e ect on symptoms, i.e.
only include patients where small particle size meal clearly a ected
the emptying rate from the stomach. A tendency towards a bet-
ter symptomatic response to the small particle size diet in patients
with less severe delay in gastric emptying at baseline was indeed
observed, but this association was modest, and not of su cient
strength to be clinically useful to choose patients for this therapy.
Moreover, the gastric emptying rate, measured with standard gas-
tric scintigraphy, which improved somewhat in both groups at
follow-up, tended to improve more a er 20 weeks with the small
particle size diet than in the control group, but this was not related
to the improvement in symptoms.  erefore, symptom improve-
ment is probably more related to the direct e ect of the meal,
rather than via a permanent e ect of the diet on gastric emptying /
motility. Another potential problem is recall bias when reporting
symptoms, as we asked for symptom severity during the preceding
two weeks rather than using a daily diary. Further, the patients we
included were seen at a secondary / tertiary care center and several
of them had severe diabetes with multiple complications, so these
ndings may not be generalized to a less severely a ected group of
patients with diabetes and gastroparesis.  ere was also an imbal-
ance in the distribution of diabetes type 1 and 2 in the treatment
groups, but as the symptomatic response did not di er between
patients with diabetes type 1 and 2, this imbalance is unlikely to
explain the positive e ect of the small particle size diet.
To conclude, in this randomized, controlled trial, we have dem-
onstrated that a diet with small particle size improves the key upper
GI symptoms of gastroparesis in patients with diabetes mellitus.  is
should be incorporated in dietary advice given to patients with diabetic
gastroparesis. However, the e ect of this diet on nutrient intake, glyc-
emic control and quality of life in the long term needs further studies.
e authors would like to express their gratitude to Nils-Gunnar
Pehrsson and Mattias Molin, Statistical Consulting Group AB, SE-
413 19 Gothenburg for statistical advice.
Guarantor of the article: Magnus Simr é n, MD, PhD.
Speci c author contributions: E.A.O., S.A., and M.S. designed the
study. E.A.O. and S.S. gave dietary advice. M.I. and H.G. analyzed
the gastric scintigraphies. E.A.O. and M.S. analyzed the data. E.A.O.,
S.A. and M.S. dra ed the manuscript, E.A.O., S.A. and M.S. provided
funding for the study. All co-authors critically revised the manuscript.
Financial support: M.S. has received support from the Swed-
ish Medical Research Council (grants 13409, 21691 and 21692),
the Marianne and Marcus Wallenberg Foundation, the Centre for
Person-Centred Care (GPCC), Sahlgrenska Academy, University of
Gothenburg and by the Faculty of Medicine, University of Gothen-
burg. E.A.O. has received research support from Swedish Nutrition
Foundation, Lund, the V ä stra G ö taland Region, Sahlgrenska Univer-
sity Hospital Foundations, the Diabetes Association in Gothenburg
and sponsorship for the cuvettes for analysis of plasma glucose from
Hemocue AB, Ä ngelholm.
Potential competing interest: Magnus Simr é n has received unre-
stricted research grants from Danone, Arla Foods and AstraZeneca,
and served as a Consultant / Advisory Board member for Danone,
Novartis, Almirall, and Shire / Movetis. No other con icts of interest
relevant to this article were reported.
Study Highlights
3 Gastroparesis is a well-known complication to diabetes
3 Dietary advice is considered to be of importance to reduce
gastrointestinal (GI) symptoms in patients with diabetic
gastroparesis, but no randomized controlled trials exist.
3 A diet with small particle size improved the key gastroparet-
ic symptoms nausea / vomiting, postprandial fullness and
bloating in patients with diabetic gastroparesis.
3 No such effect was seen when patients were advised to eat
a diet normally recommended to patients with diabetes
mellitus (DM), modifi ed based on current dietary recom-
mendations for gastroparesis.
3 Patients with diabetic gastroparesis should be advised to
eat a diet with small particle size in order to improve upper
GI symptoms.
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The American Journal of GASTROENTEROLOGY VOLUME 104 | XXX 2012
Olausson et al.
Table A1 . Intervention dietsmall particle size food
Poorly digestible food Medium digestible food Easily digestible food
Vegetables and roots
Raw: carrots, turnip, parsnips Cooked: carrots, turnip, parsnips Mashed turnips, mixed beetroot pickled beet
Cooked caulifl ower and broccoli stem Cooked caulifl ower fl ower, broccoli fl ower
Asparagus stalk Asparagus tip
Green pea Green pea pur é e
Boiled corn (Cooked and mixed) corn pat é
Cooked beans (Cooked and mixed) beans pat é
Cooked brussels sprouts (Cooked and mixed) brussels sprout pat é
Raw and cooked cabbage
Raw, boiled, and fried mushrooms Mixed mushrooms Mushroom paste
Boiled and fried onion Fine mixed onion, dried powdered onion
Cooked leeks Mixed leeks
Salad, cucumber, tomatoes Canned crushed tomatoes Tomato paste
Pepper Pepper without skin Mixed pepper
Avocado Mashed avocado
Fruit and berry
Fresh fruit Cooked and canned fruit or berry Puree of fruit or berry
Skin and membrane of citrus:
Orange, clementine, grapefruit
Pineapple Ripe pears without skin Ripe pears without skin, canned peach
Raspberries, strawberries Gooseberries
Blueberries, currant, and lingo berries Mixed: blueberries, currant and lingo berries
Blackberry, cloudberries
Green and green-yellow banana Yellow banana Yellow-brown banana
Netted melon Kiwi, soft gala melon Mixed kiwi, water melon
Mango, papaya
Nuts and Almonds
Fruits and almonds Flour of fruits and almonds
Fried potatoes, french potatoes Boiled potatoes, baked potatoes Mashed potatoes, pressed potatoes, creamed potatoes
Pasta and rice
Parboiled rice and brown rice, non-parboiled rice
Bulgur, couscous, porridge
White fresh bread Wholegrain cereal fl our bread Brown crisp
Bread with seeds and whole grains Bread baked on coarse fl our Bread baked on whole meal fl our, rye crisp, rusks
Fat cheese, ripened cheese Cottage cheese Processed cheese, spreadable cheese, quark
Hard-boiled eggs, soft-boiled eggs Mashed-boiled eggs, french omelet
Scrambled eggs made in frying pan Scrambled eggs made in pot Baked omelet Swedish style, baked egg
Butter pudding
Table A1 continued on following page
© 2014 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY
A Small Particle Size Diet in Diabetic Gastroparesis
Table A2 . Control dietlarge particle size food
Dietary treatment
Free intake of beverages containing < 0.5 g carbohydrates / 100 ml ready
to drink beverages
Preparations to choose
Raw or lightly cooked vegetables
Fresh fruit and berries
Foods providing good metabolic control
Bread made of whole grain and whole grain fl our
Rice and pasta rather than potatoes
Potatoes are allowed only in combination with raw or light cooked
Pasta and rice with long-cooking rather than with short-cooking time
Combination of food items to improve glycemic index
Food items to avoid
Mashed potatoes and mashed turnips
Other mashed or mixed foods
Breads made of fl our without grains and / or sourdough
Fruit or berry compote or cream
Canned vegetables
Porridge, corn fl akes and gruel
Smooth soup
Sweet drinks
Table A1 . Continued
Poorly digestible food Medium digestible food Easily digestible food
Whole meat Minced meat dishes Mixed minced dishes, sausage
Jellied veal
Extra thin slices of ham
Fish and seafood
Cured salmon, smoked salmon Baked salmon Baked fl atfi sh, boiled fi sh loaf dishes, fi sh pudding
Raw spiced salmon Baked mackerel baked cod fi sh Fish souffl é , fi sh balls, fi sh pate, fi sh gratin herring terrine
Shrimp, crab, clams, tails Mixed shrimp, crab, clams, tails
Cooking methods
Raw, wok Cooked, canned Puree, mixed, pate, timbale, sauces
Fried in a pan, deep fried, wok Roasted, baked Cooked
Coating with egg and breadcrumbs
Coating with breadcrumbs
Fat cooking methods Lean cooking methods
... Foods that are blended, mashed, or ground as well as high calorie liquids are an encouraged alternative to solid meals [9]. As an example, on a diet consisting of small particle-sized solids, reflux symptoms, fullness, nausea, vomiting and bloating (but not abdominal pain) improved in a randomized, controlled study in patients with diabetic Gp [11]. ...
... Indeed, published consensus guidelines for the management of Gp in adults encourage the use of medication for nausea and vomiting [1,3]. Although anti-nausea medications can be helpful, studies also have shown improvement in nausea and vomiting after dietary modifications [11]. ...
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Background Gastroparesis is delayed gastric emptying in the absence of obstruction; dietary modifications are first-line treatment. However, we do not know the factors related to provision of dietary recommendations. Methods We sought to determine how often pediatric patients with gastroparesis receive dietary education (from a gastroenterology provider vs dietitian), the recommendations given, and factors related to these outcomes. We performed a retrospective chart review of children 2- to 18-years-old managed by pediatric gastroenterology providers at our institution. Patient demographics and clinical data, dietary advice given (if any), and dietitian consultation (if any), practice location, and prokinetic use were captured. An adjusted binomial regression model identified factors associated with dietary education provision, dietitian consultation, and diet(s) recommended. Results Of 161 patients who met criteria, 98 (60.8%) received dietary education and 42 (26.1%) met with a dietitian. The most common recommendation by gastroenterology providers and dietitians was diet composition adjustment (26.5% and 47.6%, respectively). Patients with nausea/vomiting were less likely to receive dietary education or be recommended to adjust diet composition. Patients with weight loss/failure to thrive were more likely to receive dietitian support. Patients seen in the community vs medical center outpatient setting were more likely to be recommended a low-fat diet. Conclusions Only a little over half of children with gastroparesis receive dietary education and use of a dietitian’s expertise is much less frequent. Symptoms and clinical setting appear related to what, where, and by whom guidance is provided.
... Patients should continue to take fluids during their meals and sit or stand for up to two hours after eating. In contrast to a normal diabetic diet, low particle dietary intake may also help with symptoms and tolerance [121]. ...
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Diabetic gastroparesis (DG) is one of the many complications of diabetes mellitus (DM). Even though this condition surfaces years after uncontrolled disease, it affects the quality of life in several ways and causes significant morbidity. Common symptoms experienced by the patients include postprandial nausea, vomiting, abdominal fullness, and pain. Strict glycemic control is essential to evade the effects of DG. The purpose of this review article is to briefly study the pathophysiology, clinical features, diagnostic modalities, and the effects of DG on different aspects of life. Furthermore, it also focuses on the emerging treatment modalities for DG. Tradipitant and relamorelin are two such treatment options that are gaining noteworthy recognition and are discussed in detail in this review article. As observed through various clinical trials, these drugs help alleviate symptoms like nausea, vomiting, abdominal pain, and bloating in patients suffering from DG, thereby targeting the most common and bothersome symptoms of the disease. This leads to an improvement in the quality of life, making it a reliable treatment option for this disease. But while pharmacological intervention is vital, psychological support and lifestyle changes are equally important and are the reason why a multidisciplinary approach is required for the treatment of DG.
... GE is often assessed primarily through GES to evaluate the efficacy of dietary treatment. Two recent randomized controlled trials (RCTs) have shown that a small particle diet appears to improve GE and relieve symptoms in patients with GP who experience predominant abdominal discomfort [97,98]. Therefore, this dietary recommendation should be considered for this phenotype of GP [99]. ...
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Gastroparesis (GP) is a chronic disease characterized by upper gastrointestinal symptoms, primarily nausea and vomiting, and delayed gastric emptying (GE), in the absence of mechanical GI obstruction. The underlying pathophysiology of GP remains unclear, but factors contributing to the condition include vagal nerve dysfunction, impaired gastric fundic accommodation, antral hypomotility, gastric dysrhythmias, and pyloric dysfunction. Currently, gastric emptying scintigraphy (GES) is considered the gold standard for GP diagnosis. However, the overall delay in GE weakly correlates with GP symptoms and their severity. Recent research efforts have focused on developing treatments that address the presumed underlying pathophysiological mechanisms of GP, such as pyloric hypertonicity, with Gastric Peroral Endoscopic Myotomy (G-POEM) one of these procedures. New promising diagnostic tools for gastroparesis include wireless motility capsule (WMC), the 13 carbon-GE breath test, high-resolution electrogastrography, and the Endoluminal Functional Lumen Imaging Probe (EndoFLIP). Some of these tools assess alterations beyond GE, such as muscular electrical activity and pyloric tone. These modalities have the potential to characterize the pathophysiology of gastroparesis, identifying patients who may benefit from targeted therapies. The aim of this review is to provide an overview of the current knowledge on diagnostic pathways in GP, with a focus on the association between diagnosis, symptoms, and treatment.
... 40 A prospective, 20-week parallel group dietary intervention study in diabetic patients (n = 56; 36 with type I diabetes) found that a small particle diet substantially improved symptoms of early satiety, bloating, nausea and vomiting compared to a large particle diet. 41 A retrospective analysis of 86 patients with GP found that a low-fiber, low-fat, small frequent meal diet combined with prokinetic therapy ...
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Gastroparesis (GP), a historically vexing disorder characterized by symptoms of nausea, vomiting, abdominal pain, early satiety, and/or bloating, in the setting of an objective delay in gastric emptying, is often difficult to treat and carries a tremendous burden on the quality of patients' lives, as well as the healthcare system in general. Though the etiology of GP has been fairly well defined, much work has been done recently to better understand the pathophysiology of GP, as well as to identify novel effective and safe treatment options. As our understanding of GP has evolved, many myths and misconceptions still abound in this rapidly changing field. The goal of this review is to identify myths and misconceptions regarding the etiology, pathophysiology, diagnosis, and treatment of GP, in the context of the latest research findings which have shaped our current understanding of GP. Recognition and dispelling of such myths and misconceptions is critical to moving the field forward and ultimately advancing the clinical management of what will hopefully become a better understood and more manageable disorder in the future.
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The prevalence of abdominal pain in gastroparesis ranges from 42 to 89%. Severe/very severe abdominal pain is often correlated with somatization, psychiatric conditions, and opioid use and affects the quality of life significantly. Treatment of abdominal pain in gastroparesis is complex and based on pathophysiology: phenotypes and endotypes of gastroparesis. However, the pathophysiology of gastroparesis itself is not clearly known, which makes its treatment more intriguing. In this article, we reviewed details of the pathophysiology and treatment modalities of abdominal pain in gastroparesis. Advances in electrogastrogram technology such as high-resolution electrogastrogram are evolving to categorize the overlapping symptom profiles. There is emerging data about full-thickness gastric biopsy findings to understand the pathophysiologic changes in gastroparesis, but its clinical implications on management decisions are yet to be explored. Bioelectric procedures and endoscopic and surgical techniques for refractory gastroparesis have been relatively new areas of research interest. Despite reassuring results in some research studies, abdominal pain relief by those invasive therapeutic modalities needs to be further investigated through large clinical trials with both short-term and long-term follow-up of therapeutic efficacy and complications. Management of abdominal pain-predominant gastroparesis and gastroparesis-like syndromes are challenging, similar to chronic pain management; however, due to its potential significant impact on quality of life, further research is warranted to explore the individualized treatment options based on the pathophysiology of gastroparesis and gastroparesis-like syndromes.
Background: Patients with symptoms of gastroparesis (Gp) often modify their diets and consume small meals. However, the relationship between patients' eating behavior and their gastric emptying is not well understood. This study describes meal-eating characteristics of patients with Gp symptoms and relates them to severity of emptying delay. Methods: Adult patients with Gp symptoms underwent 4-h gastric emptying scintigraphy and completed questionnaires including the Patient Assessment of GI Symptoms, a nutrition and diet questionnaire, and the Meal Patterns Questionnaire. Key results: Of 119 patients with Gp symptoms, 35 had normal gastric emptying (≤10% gastric retention at 4 h), 26 mildly delayed (>10%-20%), 28 moderately delayed (>20%-35%), and 30 severely delayed (>35%). Most patients (85%) reported eating small meals with an average of 2.4 meals per day. The most common reasons for stopping eating a meal were feeling full (83%), nausea (46%), and abdominal pain (31%). As gastric emptying worsened, patients increasingly made diet modifications such as low-fat, low-fiber, Gp diet, oral supplements, and blenderized meals (r = 0.309, p = 0.0007). Postprandial fullness lasted for 351 ± 451 min for patients with severely delayed emptying versus 207 ± 173 min for patients with normal emptying (p = 0.19). Conclusions & inferences: Meal-eating characteristics were found to vary with severity of gastric retention. Patients with severely delayed gastric emptying reported the longest duration of postprandial fullness. Dietary modification increased significantly with gastric retention. These meal-eating characteristics are important to understand as they impact on dietary education given to Gp patients for symptom management.
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The combined research aim of this thesis was to investigate whether beneficial dietary modification using soluble dietary fibre was viable in patients with gastroparesis. To find an answer to this question, three different investigative approaches were required, namely, rheological analysis, mass spectrometric monomer characterisation, and clinical investigation in a pilot cohort of gastroparesis patients. A multidisciplinary approach was required since there are current knowledge gaps regarding the potential viability of soluble fibres in patients with gastroparesis. This thesis tries to identify suitable “low-viscosity” type soluble dietary fibres in Chapter 2 using rheology. Among the ten different soluble fibres tested, partially hydrolysed guar gum (PHGG) and gum Arabic displayed the most promising “low-viscosity” characteristics under simulated digestion. Therefore, they were selected for a pilot clinical study analysing their short-term effects in mild-to- moderate symptom gastroparesis patients (no enteral tube feeding). The pilot study (n = 10) in Chapter 3 was designed as a crossover study with PHGG and gum Arabic as test fibres, with “high-viscosity” psyllium husk as the positive control and water as the negative control against a glucose challenge. The pilot study demonstrated that PHGG and gum Arabic were very tolerable, cause very few increases in symptoms (similar to water), while displaying glycaemic index lowering (low-GI) properties similar to the positive control psyllium husk. Therefore, both PHGG and gum Arabic were determined to be viable supplements for a future long-term study in gastroparesis patients. The monomer components of major polysaccharides in the PHGG, gum Arabic and psyllium husk supplements were characterised in Chapter 4 using a rapid (21.0 min) HPLC-ESI-Q-ToF-MS method that was specifically developed and validated. In total, separation of nine monomer sugar analytes was achieved using sample derivatization, with five monomers being identified and quantified in PHGG, gum Arabic and psyllium husk. The method displayed very good linearity R2 ≥ 0.999 and recoveries (96.22 – 109.49%). The developed method will be very useful for standardisation and labelling of commercial prebiotic soluble dietary fibre supplements. In summary, a multi-disciplinary approach investigated the rheological behaviour, clinical effects, chemical composition and the potential viability of “low-viscosity” soluble fibre in gastroparesis patients.
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This guideline presents recommendations for the evaluation and management of patients with gastroparesis. Gastroparesis is identified in clinical practice through the recognition of the clinical symptoms and documentation of delayed gastric emptying. Symptoms from gastroparesis include nausea, vomiting, early satiety, postprandial fullness, bloating, and upper abdominal pain. Management of gastroparesis should include assessment and correction of nutritional state, relief of symptoms, improvement of gastric emptying and, in diabetics, glycemic control. Patient nutritional state should be managed by oral dietary modifications. If oral intake is not adequate, then enteral nutrition via jejunostomy tube needs to be considered. Parenteral nutrition is rarely required when hydration and nutritional state cannot be maintained. Medical treatment entails use of prokinetic and antiemetic therapies. Current approved treatment options, including metoclopramide and gastric electrical stimulation (GES, approved on a humanitarian device exemption), do not adequately address clinical need. Antiemetics have not been specifically tested in gastroparesis, but they may relieve nausea and vomiting. Other medications aimed at symptom relief include unapproved medications or off-label indications, and include domperidone, erythromycin (primarily over a short term), and centrally acting antidepressants used as symptom modulators. GES may relieve symptoms, including weekly vomiting frequency, and the need for nutritional supplementation, based on open-label studies. Second-line approaches include venting gastrostomy or feeding jejunostomy; intrapyloric botulinum toxin injection was not effective in randomized controlled trials. Most of these treatments are based on open-label treatment trials and small numbers. Partial gastrectomy and pyloroplasty should be used rarely, only in carefully selected patients. Attention should be given to the development of new effective therapies for symptomatic control.Am J Gastroenterol advance online publication, 13 November 2012; doi:10.1038/ajg.2012.373.
The Diabetes Control and Complications Trial has demonstrated that intensive diabetes treatment delays the onset and slows the progression of diabetic complications in subjects with insulin-dependent diabetes mellitus from 13 to 39 years of age. We examined whether the effects of such treatment also occurred in the subset of young diabetic subjects (13 to 17 years of age at entry) in the Diabetes Control and Complications Trial. One hundred twenty-five adolescent subjects with insulin-dependent diabetes mellitus but with no retinopathy at baseline (primary prevention cohort) and 70 adolescent subjects with mild retinopathy (secondary intervention cohort) were randomly assigned to receive either (1) intensive therapy with an external insulin pump or at least three daily insulin injections, together with frequent daily blood-glucose monitoring, or (2) conventional therapy with one or two daily insulin injections and once-daily monitoring. Subjects were followed for a mean of 7.4 years (4 to 9 years). In the primary prevention cohort, intensive therapy decreased the risk of having retinopathy by 53% (95% confidence interval: 1% to 78%; p = 0.048) in comparison with conventional therapy. In the secondary intervention cohort, intensive therapy decreased the risk of retinopathy progression by 70% (95% confidence interval: 25% to 88%; p = 0.010) and the occurrence of microalbuminuria by 55% (95% confidence interval: 3% to 79%; p = 0.042). Motor and sensory nerve conduction velocities were faster in intensively treated subjects. The major adverse event with intensive therapy was a nearly threefold increase of severe hypoglycemia. We conclude that intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy and nephropathy when initiated in adolescent subjects; the benefits outweigh the increased risk of hypoglycemia that accompanies such treatment. (J PEDIATR 1994;125:177-88)
BACKGROUND Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications. METHODS A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly. RESULTS In the primary-prevention cohort, intensive therapy reduced the adjusted mean risk for the development of retinopathy by 76 percent (95 percent confidence interval, 62 to 85 percent), as compared with conventional therapy. In the secondary-intervention cohort, intensive therapy slowed the progression of retinopathy by 54 percent (95 percent confidence interval, 39 to 66 percent) and reduced the development of proliferative or severe nonproliferative retinopathy by 47 percent (95 percent confidence interval, 14 to 67 percent). In the two cohorts combined, intensive therapy reduced the occurrence of microalbuminuria (urinary albumin excretion of ≥ 40 mg per 24 hours) by 39 percent (95 percent confidence interval, 21 to 52 percent), that of albuminuria (urinary albumin excretion of ≥ 300 mg per 24 hours) by 54 percent (95 percent confidence interval, 19 to 74 percent), and that of clinical neuropathy by 60 percent (95 percent confidence interval, 38 to 74 percent). The chief adverse event associated with intensive therapy was a two-to-threefold increase in severe hypoglycemia. CONCLUSIONS Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy, nephropathy, and neuropathy in patients with IDDM.
We document the applicability of the SF-36 Health Survey, which was translated into Swedish using methods later adopted by the International Quality of Life Assessment (IQOLA) Project procedures. To test its appropriateness for use in Sweden, it was administered through mail-out/mail-back questionnaires in seven general population studies with an average response rate of 68%. The 8930 respondents varied by gender (48.2% men), age (range 15–93 years, mean age 42.7), marital status, education, socio-economic status, and geographical area. Psychometric methods used in the evaluation of the SF-36 in the U.S. were replicated. Over 90 % of respondents had complete items for each of the eight SF-36 scales, although more missing data were observed for subjects 75 years and over. Scale scores could be computed for the vast majority of respondents (95% and over); slightly fewer in the oldest subgroup. Item-internal consistency was consistently high across socio-demographic subgroups and the eight scales. Most reliability estimates exceeded the 0.80 level. The highest reliability was observed for the Bodily Pain Scale where all subgroups met the 0.90 level recommended for individual comparisons; coefficients at or above 0.90 were also observed in most subgroups for the Physical Functioning Scale. Tests of scaling assumptions including hypothesized item groupings, which reflect the construct validity of scales, were consistently favorable across subgroups, although lower rates were noted in the oldest age group. In conclusion, these studies have yielded empirical evidence supporting the feasibility of a non-English language reproduction of the SF-36 Health Survey. The Swedish SF-36 is ready for further evaluation.
Background Scintigraphy, the gold standard to measure gastric emptying, is expensive and not widely available. Therefore, we compared emptying of radiopaque markers (ROM) from the stomach, by use of fluoroscopy, with scintigraphy in patients with insulin-treated diabetes. Methods On the same day we measured gastric emptying of 20 ROM using fluoroscopy and scintigraphic emptying of a standard solid meal. The subjects also completed a validated gastrointestinal (GI) symptom questionnaire. Key Results We included 115 patients with insulin-treated diabetes (median age 53, range 21–69 years; 59 women). A moderately strong correlation was demonstrated between scintigraphic (% retained at 2 h) and ROM emptying (markers retained at 6 h) (r = 0.47; P < 0.0001). Eighty-three patients had delayed gastric emptying with scintigraphy, whereas only 29 patients had delayed emptying of ROM. Of the 29 patients with delayed emptying of ROM, 28 also had delayed scintigraphic emptying. The sensitivity and specificity of the ROM test was 34% and 97%, respectively. Significant correlations were only noted between scintigraphic gastric emptying and GI symptom severity, with the strongest correlations for fullness/early satiety (r = 0.34; P < 0.001) and nausea/vomiting (r = 0.30; P < 0.001). Conclusions & Inferences A gastric emptying test with ROM is a widely available screening method to detect delayed gastric emptying in patients with diabetes, where a positive result seems reliable. However, a normal ROM test does not exclude delayed gastric emptying, and if the clinical suspicion of gastroparesis remains, scintigraphy should be performed. Results from scintigraphy also correlate with GI symptom severity, which ROM test did not.
There is growing demand for translations of health status questionnaires for use in multinational drug therapy studies and for population comparisons of health statistics. The International Quality of Life Assessment (IQOLA) Project is conducting a three-stage research program to determine the feasibility of translating the SF-36 Health Survey, widely used in English-speaking countries, into other languages. In stage 1, the conceptual equivalence and acceptability of translated questionnaires are evaluated and improved using qualitative and quantitative methods. In stage 2, assumptions underlying the construction and scoring of questionnaire scales are tested empirically. In stage 3, the equivalence of the interpretation of questionnaire scores across countries is tested using methods that closely approximate their intended use, and empirical results are compared. Data analyses from Sweden and the United Kingdom, as well as other research cited, support the feasibility of cross-cultural health measurement using the SF-36.
Gastrointestinal (GI) symptoms are common in patients with long-standing diabetes mellitus, but the pathogenesis is controversial. We aimed to determine if GI symptoms are linked to psychological distress in diabetes. A consecutive sample of outpatients with diabetes mellitus (n = 209) and a random sample of community diabetics (n = 892) completed a validated questionnaire measuring GI symptoms, the Hospital Anxiety and Depression (HAD) Scale for anxiety and depression, and the Eysenck short neuroticism scale. Overall, 42% reported one or more GI symptoms: bloating, abdominal pain, loose stools, and urgency were most common. The mean HAD and neuroticism scores were significantly higher for most GI symptoms (11 of 14, all p < 0.05), and a dose-response relationship was observed. GI symptoms were, in general, approximately twice as frequent in cases with anxiety or depression (HAD > or = 11). Anxiety, depression, and neuroticism were each independently associated with the number of GI symptoms, adjusting for age, gender, duration and type of diabetes, and self-reported glycemic control. Increased levels of state anxiety and depression and neuroticism are associated with upper and lower GI symptoms in diabetes mellitus. It is uncertain whether psychological distress is causally linked to symptoms, or whether GI symptoms per se increase levels of anxiety and depression.