[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE
To check the hypothesis that myo-inositol supplementation may reduce gestational diabetes mellitus (GDM) onset in pregnant women with a family history of type 2 diabetes.RESEARCH DESIGN AND METHODSA 2-year, prospective, randomized, open-label, placebo-controlled study was carried out in pregnant outpatients with a parent with type 2 diabetes who were treated from the end of the first trimester with 2 g myo-inositol plus 200 µg folic acid twice a day (n = 110) and in the placebo group (n = 110), who were only treated with 200 µg folic acid twice a day. The main outcome measure was the incidence of GDM in both groups. Secondary outcome measures were as follows: the incidence of fetal macrosomia (>4,000 g), gestational hypertension, preterm delivery, caesarean section, shoulder dystocia, neonatal hypoglycemia, and neonatal distress respiratory syndrome. GDM diagnosis was performed according to the International Association of Diabetes in Pregnancy Study Group (IADPSG) recommendations.RESULTSIncidence of GDM was significantly reduced in the myo-inositol group compared with the placebo group: 6 vs. 15.3%, respectively (P = 0.04). In the myo-inositol group, a reduction of GDM risk occurrence was highlighted (odds ratio 0.35). A statistically significant reduction of fetal macrosomia in the myo-inositol group was also highlighted together with a significant reduction in mean fetal weight at delivery. In the other secondary outcome measures, there were no differences between groups.CONCLUSIONS myo-Inositol supplementation in pregnant women with a family history of type 2 diabetes may reduce GDM incidence and the delivery of macrosomia fetuses.
Diabetes care 01/2013; 36(4). DOI:10.2337/dc12-1371 · 8.42 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: ABSTRACT Objective To evaluate the 12-month effect of myo-inositol treatment on some biochemical parameters of women affected by metabolic syndrome. Methods Eighty outpatient postmenopausal women, affected by metabolic syndrome, were enrolled in a 12-month study. All women were treated with a low-energy diet, and then they were randomly assigned to myo-inositol 2 g b.i.d. (n = 40) or placebo (n = 40). All the women were evaluated for serum glucose, insulin, HOMA-IR (Homeostasis Model Assessment-Insulin Resistance), triglycerides, total and high density lipoprotein cholesterol, body mass index (BMI), waist circumference and blood pressure at baseline and after 12 months of treatment. Results With the exception of BMI and waist circumference, after 12 months of treatment, all the parameters studied showed a significant improvement in the myo-inositol group compared to the control group. At the end of the study, in the myo-inositol group, the number of women without metabolic syndrome was eight (20%) whereas, in the control group, only one woman no longer had the metabolic syndrome after 12 months of diet. Conclusions Myo-inositol might be considered one of the insulin-sensitizing substances in the treatment of metabolic syndrome.
[Show abstract][Hide abstract] ABSTRACT: The aim of this study was to determine the effects of maternal prepregnancy body mass index (BMI) and weight gain during pregnancy on perinatal outcome in non-diabetic women.
The clinical records of consecutive women who had undergone a glucose challenge test (GCT) and then delivered in our university hospital between January 2004 and December 2009 were retrospectively reviewed. Prepregnancy BMI and pregnancy weight gain were classified according to the US Institute of Medicine guidelines (1990).
Of the eligible 2225 patients, obese and overweight women had a greater percentage of macrosomic babies (17.7% and 8.9%, respectively) compared with normal weight women (4.5%). However, when considered according to weight gain during pregnancy, the results were statistically significant only for excess weight gain in the obese (OR: 8.3, 95% CI: 2.4-28.4) and overweight (OR: 2.9, 95% CI: 1.2-6.8) groups. Also, the surgical delivery rate was significantly higher in the obese vs normal weight women (56% vs 36%, respectively) although, in this case, there was no difference according to normal and excess weight gain during pregnancy (OR: 1.4, 95% CI: 0.7-2.6).
Overweight and obese women have an increased risk rate of macrosomia that can be limited by well-controlled weight gain during pregnancy. There was also a significantly higher rate of surgical delivery in the obese compared with the normal weight group that was, however, independent of excessive weight gain during pregnancy.
[Show abstract][Hide abstract] ABSTRACT: To test the hypothesis that myoinositol supplementation will improve insulin sensitivity as measured by markers of insulin resistance such as homeostasis model assessment of insulin resistance and adiponectin in women with gestational diabetes.
The trial was carried out in diet-treated patients with gestational diabetes diagnosed in our department between April 2008 and September 2009. Subjects were randomly assigned to receive either myoinositol supplementation (4 g daily) plus folic acid (400 μg daily)-the study group-or folic acid only (400 μg daily)-the control group. Both groups received the same diet prescription. Homeostasis model assessment of insulin resistance and adiponectin were assayed while fasting at the time of the diagnostic oral glucose tolerance test and after 8 weeks of treatment.
There were 69 evaluable patients, 24 in the study group and 45 in the control group. Fasting glucose and insulin, and consequently homeostasis model assessment of insulin resistance, decreased in both groups (50% in the study group vs. 29% in the control group), but the decline in the study group was significantly greater than that in the control group (P = 0.0001). Adiponectin increased in the myoinositol group while it decreased in the control group (P = 0.009).
Myoinositol improves insulin resistance in patients with gestational diabetes.
Diabetic Medicine 03/2011; 28(8):972-5. DOI:10.1111/j.1464-5491.2011.03284.x · 3.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The aim of this study was to evaluate whether myo-inositol, an insulin-sensitizing substance, may improve some features of metabolic syndrome in postmenopausal women.
Eighty postmenopausal women affected by the metabolic syndrome were enrolled prospectively in the study and treated with diet plus supplementation of myo-inositol (2 g BID plus diet: intervention group) or with diet plus placebo (control group) for 6 months. They were evaluated at baseline and after 6 months for insulin resistance (homeostasis model assessment ratio [HOMA] insulin resistance), lipid profile, and blood pressure.
Myo-inositol plus diet improved systolic and diastolic blood pressure, HOMA index, cholesterol, and triglyceride serum levels with highly significant differences, compared with the groups treated only with diet and placebo. In the group treated with myo-inositol, a decrease in diastolic blood pressure (-11%), HOMA index (-75%), and serum triglycerides (-20%) and an improvement in high-density lipoprotein cholesterol (22%) were shown.
Supplementation with myo-inositol may be considered a reliable option in the treatment of metabolic syndrome in postmenopausal women.
Menopause (New York, N.Y.) 01/2011; 18(1):102-4. DOI:10.1097/gme.0b013e3181e8e1b1 · 3.36 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Endometrial hyperplasia without cytological atypia is commonly treated with progestins, but other treatment regimes may be available with equivalent efficacy and low side effects.
A randomized double-blind, placebo and progesterone-controlled clinical trial to evaluate the effects of genistein aglycone in reducing endometrial hyperplasia.
A group of 56 premenopausal women with non-atypical endometrial hyperplasia were enrolled and received: genistein aglycone (n=19; 54 mg/day); norethisterone acetate (n=19; 10 mg/day on days 16-25 of the menstrual cycle) or placebo (n=18) for 6 months.
Hysteroscopy was performed with biopsies and symptomology assessed at baseline, 3 and 6 months of administration. The effect on estrogen (ER) and progesterone receptors (PR) expression in uterine biopsies were assessed after 3 and 6 months. For each treatment follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), sex hormone-binding globulin (SHBG) and progesterone (PG) levels were also evaluated.
After 6 months, 42% of genistein aglycone-administered subjects had a significant improvement of symptoms (histologically confirmed in the 29%) compared to 47% of norethisterone acetate subjects (histologically confirmed in the 31%), but only 12% in the placebo group with 19% exhibiting worsening symptoms and increased endometrial thickness. No significant differences were noted for hormone levels for any treatment, but immunohistochemical analysis revealed significantly reduced staining for ER-alpha and PR and enhanced ER-beta1 staining in genistein-administered subjects associated with a complete regression of bleeding.
These results suggest that genistein aglycone might be useful for the management of endometrial hyperplasia without atypia in women that cannot be treated with progestin.
Phytomedicine: international journal of phytotherapy and phytopharmacology 09/2010; 17(11):844-50. DOI:10.1016/j.phymed.2010.03.024 · 3.13 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Neutrophil gelatinase-associated lipocalin (NGAL) was evaluated prospectively through normal pregnancy and pregnancies complicated by preeclampsia syndrome. Sixty women enrolled in the study were evaluated for serum NGAL levels at 9-11 weeks gestation, at 24-26 weeks gestation and at delivery. Thirty women were affected by preeclampsia and 30 women with uncomplicated pregnancies formed the control group. NGAL serum concentrations in the preeclampsia group were higher compared to the control group, with significant differences in each trimester. In the first trimester, the median values were: 29.9 ng/mL [interquartile range (IQR) 24.1-50.1] versus 13.6 ng/mL (IQR 9.1-19.9; p < 0.001); in the second trimester: 59.6 ng/mL (IQR 25.3-82.6) versus 16.3 ng/mL (IQR 11.3-23.3; p < 0.001); and in the third trimester: 57.2 ng/mL (IQR 18.7-70.9) versus 15.8 ng/mL (IQR 9.1-22.5; p < 0.001). NGAL serum values were positively correlated with systolic and diastolic blood pressure and with proteinuria.
[Show abstract][Hide abstract] ABSTRACT: Neutrophil gelatinase-associated lipocalin (NGAL) is highly expressed in damaged epithelia, during inflammation and cardiovascular disease. Soluble NGAL was measured in women who subsequently developed gestational diabetes.
From a cohort of 908 pregnant outpatients who participated in a screening programme for Down's syndrome at 9-12 weeks of gestation, we considered all 41 women with a singleton pregnancy, who developed gestational diabetes in the previous 12 months, and a control group of 82 normal pregnancies. Circulating NGAL and insulin resistance by homeostasis model assessment ratio (HOMA-IR) were determined in the first trimester.
Median serum NGAL concentrations were higher in the gestational diabetes group [51.3 ng/ml (39.8-66.1 ng/ml)] compared with the control group [17.8 ng/ml (15.5-20.9 ng/ml)] (P < 0.001) and positively correlated with HOMA-IR (P < 0.001).
In the first trimester, circulating NGAL was significantly increased in women who subsequently developed gestational diabetes compared with the control group.
Diabetic Medicine 12/2009; 26(12):1293-5. DOI:10.1111/j.1464-5491.2009.02830.x · 3.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate which pregnant women with a single abnormal value in the oral glucose tolerance test are at increased risk for adverse perinatal outcome.
In this retrospective cohort study, we have evaluated the course of pregnancy in 152 consecutive women with only one abnormal value (OAV), and 624 with a 100 g - glucose tolerance test totally within the range values.
The prevalence of caesarean delivery, hypertensive disorders and macrosomia was higher in the study group when compared with the control group, whereas no difference was noted concerning gestational age at delivery, Apgar score at 1 and 5 min and neonatal hypoglycemia. Moreover, in the study group hypertensive disorders were more frequent in the subgroup with the elevated value at 1 h after the glucose load (25%), whereas macrosomia is more frequent when it is the fasting value to be elevated (29.7%).
Our results show that the implications of a single elevated glucose tolerance test value vary in relation to the timing of the abnormal value. In fact, OAV fasting or 1-h after load has a higher prevalence for an adverse obstetric outcome, whereas a 2 or 3-h value does not present significant differences when compared with the control group.
The journal of maternal-fetal & neonatal medicine: the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians 07/2009; 22(7):597-601. DOI:10.1080/14767050902801801 · 1.37 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Neutrophil gelatinase-associated lipocalin (NGAL) concentrations, a product of neutrophils, were investigated in normal and preeclamptic pregnancies. Prospectively collected data and late second trimester (24-26 weeks) serum samples from 48 women who subsequently developed preeclampsia (PE) and 96 control women with uncomplicated pregnancies were compared. Serum NGAL values, as determined by quantitative sandwich enzyme immunoassay, were significantly increased in the preeclamptic compared to the control women: 76.9 ng/ml (interquartile range 39.7-96.5) versus 16.0 ng/ml (interquartile range 11.2-24.4) (p<0.001), and were positively correlated to blood pressure and proteinuria, showing a high sensitivity (75%) and specificity (94.5%). The results suggest that serum NGAL might be involved in the pathophysiology of PE and could be a marker for this syndrome.
[Show abstract][Hide abstract] ABSTRACT: To evaluate the ability of endoglin, placental growth factor (PlGF) and the soluble form of vascular endothelial growth factor receptor (sFlt-1) measurements in gestational weeks 24-28 were used to predict pre-eclampsia.
Observational, prospective study. Setting. Department of Gynecological, Obstetrical Sciences and Reproductive Medicine, University of Messina. Sample. Fifty-two pre-eclamptic and 52 healthy pregnant women.
A maternal serum sample was frozen and stored at 1-h 50-g glucose challenge test between 24 and 28 weeks' gestation. A second maternal serum sample was collected at admission for the onset of the disease in the pre-eclamptic group and at admission for delivery in the control group. Levels of endoglin, sFlt-1 and the PlGF were measured in the stored serum. Pre-eclamptic subjects were also divided into women with early-onset (<37 weeks) and women with late-onset pre-eclampsia (> or =37 weeks).
Levels of endoglin, sFlt-1, and sFlt-1:PlGF ratio were found to be higher in the pre-eclamptic group in both trimesters. No differences were found between early- and late-onset pre-eclamptic. The Receiver Operating Characteristics curve, applied to the second trimester marker values, showed the best diagnostic profile for sFlt-1:PlGF (area under the curve, AUC=0.92) followed by endoglin (AUC=0.88), sFlt-1 (AUC=0.87) and PlGF (AUC=0.83). This finding was confirmed by Bayesian analysis which highlighted a specificity, a sensitivity, a diagnostic accuracy, a positive predictive value and a negative predictive value of 88.5% for sFlt-1:PlGF using a cut-off of 38.47.
Endoglin, PlGF and sFlt-1 might be used as markers for predicting pre-eclampsia, but sFlt-1:PlGF seems to be more accurate.
[Show abstract][Hide abstract] ABSTRACT: The aim of the present study was to analyze the concentrations of endothelial precursor cells (EPCs) during the 3 trimesters of normal pregnancy and to compare the EPC counts in women with normal pregnancy, gestational diabetes, and gestational hypertension.
The study was conducted on 21 pregnant women with single pregnancies (age range, 22 to 35 years). EPCs were quantified by flow cytometry. The subjects were divided into 3 groups, each consisting of 7 subjects: patients with gestational diabetes; patients with gestational hypertension; patients with normal pregnancy.
A progressive increase was found in the concentrations of EPCs during pregnancy in healthy women. In the third trimester of pregnancy, the number of CD34+ cells was significantly lower in patients with gestational diabetes than in hypertensive patients and controls; no significant differences were found between the levels of circulating CD34+ cells in hypertensive patients and those in controls. There were no significant differences between the diabetic and hypertensive patients for the percentage of cells expressing CD133 and VEGFR2, whereas in both groups the percentage of CD133+/VEGFR2+ elements was significantly higher than in the healthy control subjects.
Our findings confirm that EPCs isolated from the maternal circulation increase gradually throughout the gestational trimesters. These cells were derived from the endothelial cells lineage, as demonstrated by CD133+/VEGFR2+ cell assay. Moreover, the concentration of EPCs in pregnant women with gestational diabetes and hypertension differs from that in subjects with a normal pregnancy, CD34+ cells being reduced but CD133+/VEGFR2+ cell concentrations being increased. These results not only substantiate recent insights into the mechanisms regulating maternal vascular modifications during pregnancy but also throw light upon the activation of different patterns in the mobilization of endothelial progenitor cells during pathologic states in which endothelial disorders occur.
American journal of obstetrics and gynecology 02/2007; 196(1):68.e1-6. DOI:10.1016/j.ajog.2006.08.032 · 4.70 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate the importance of adiponectin and insulin resistance in early- and late-onset pre-eclampsia.
A nested case-control study in 72 pregnant women who participated in the first-trimester Down-syndrome-screening programme and who delivered at our hospital.
University Hospital, Department of Obstetrics and Gynecology.
Pregnant women: 36 women with pre-eclampsia of which 20 late onset and 16 early onset were compared with 36 uncomplicated pregnancies who delivered at term.
In all the women, insulin resistance was calculated by the homeostasis model assessment ratio (HOMA-IR) and plasma adiponectin was determined using an enzyme-linked immunosorbent assay.
Insulin resistance and adiponectin concentration.
First-trimester plasma adiponectin mean levels in the whole pre-eclampsia group were significantly lower than that in the control group (8.4 +/- 3.3 versus 14.8 +/- 4.6 microgram/ml; P < 0.001), whereas first-trimester mean HOMA-IR values were significantly higher in the pre-eclampsia group than that in the control group (2.0 +/- 1.1 versus 1.0 +/- 0.4; P= 0.01). Plasma adiponectin concentrations at delivery in the pre-eclampsia group were significantly higher than that in the control group (9.2 +/- 3.7 versus 7.8 +/- 2.6 microgram/ml; P= 0.04). First-trimester plasma adiponectin mean concentrations in the late-onset subgroup were significantly lower compared with the concentrations in early-onset subgroup (6.2 +/- 1.4 microgram/ml versus 11.1 +/- 3.2 microgram/ml; P < 0.001), and there was a significant difference in adiponectin plasma values only between women in the late-onset pre-eclampsia group versus those in the control group (P < 0.001). First-trimester mean HOMA-IR values were significantly higher in the late-onset subgroup compared with that of the early-onset subgroup (2.5 +/- 1.3 versus 1.3 +/- 0.3; P= 0.02), and there was a significant difference only between the control group versus the late-onset subgroup (P= 0.001).
First-trimester adiponectin and HOMA-IR values seem to select two completely different populations: early- and late-onset pre-eclampsia, which might suggest a different pathogenesis.
BJOG An International Journal of Obstetrics & Gynaecology 11/2006; 113(11):1264-9. DOI:10.1111/j.1471-0528.2006.01078.x · 3.45 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Adiponectin is an exclusively adipose tissue-derived protein. Low plasma adiponectin levels have been found in hypertensive men. Our objective was to evaluate whether low first-trimester plasma adiponectin values were predictive of hypertensive disorders later in pregnancy.
A nested case-control study was carried out on a cohort of 1,842 pregnant women who participated in the first-trimester Down syndrome screening program; 34 developed preeclampsia and 48 gestational hypertension. A control group of 82 nonhypertensive uneventful pregnancies was selected. Plasma adiponectin was determined using an enzyme-linked immunosorbent assay (ELISA).
Adiponectin median concentrations in the group which subsequently became hypertensive were significantly lower than those in the control group (7.6 versus 13.0 microg/mL) (P < .001). When the 2 hypertensive subgroups were considered, the plasma adiponectin median value in the preeclampsia group was significantly lower than that in the gestational hypertension group (6.6 versus 9.3 microg/mL) (P = .01). Regression analysis showed an inverse correlation between plasma adiponectin concentrations and maternal age, gestational age, body mass index, systolic blood pressure, and proteinuria. Approximately 34% of hypertensive pregnancies, compared with 7% of controls (P < .001), had plasma adiponectin concentrations less than 6.4 microg/mL (mean value of lower quartile of distribution among control patients). After adjusting for maternal age, all these women experienced a 6.6-fold (95% confidence interval 2.5-17.8) increased risk of pregnancy hypertension, compared with those women who had higher concentrations.
Our findings suggest a strong association between hypoadiponectinemia and the risk of hypertensive disorders in pregnancy, especially with preeclampsia.
Obstetrics and Gynecology 09/2005; 106(2):340-4. DOI:10.1097/01.AOG.0000168441.79050.03 · 5.18 Impact Factor