Myo-inositol Supplementation for Prevention of Gestational Diabetes in Obese  Pregnant Women: A Randomized Controlled Trial

D'Anna R; Scilipoti A; Santamaria A; Interdonato ML; Petrella E; Neri I; Pintaudi B; Corrado F; Facchinetti F; Di Benedetto A

doi:10.1097/AOG.0000000000000958

Therapeutics Metabolic and Endocrine Agents

Myo-inositol Supplementation for Prevention of Gestational Diabetes in Obese Pregnant Women: A Randomized Controlled Trial

D'Anna R, Scilipoti A, Santamaria A, Interdonato ML, Petrella E, Neri I, Pintaudi B, Corrado F, Facchinetti F, Di Benedetto A

Published August 5, 2015 Obstetrics and Gynecology, 126(2), 310-315

DOI 10.1097/AOG.0000000000000958 PMID 26241420

RRM Academy Synopsis

Obese pregnant women on myo-inositol had less gestational diabetes

In a trial of 220 obese pregnant women, 14 of 100 on myo-inositol got gestational diabetes. On placebo, 34 of 100 did. Insulin resistance fell more with myo-inositol.

Key Findings

Among 107 women per group with glucose test results, gestational diabetes occurred in 14.0% on myo-inositol and 33.6% on placebo (P=.001).
The odds ratio for gestational diabetes was 0.34 (95% CI 0.17-0.68), and 0.30 (95% CI 0.14-0.66) after adjusting for age, BMI, weight gain, parity, ethnicity and family history.
Insulin resistance, measured by homeostasis model assessment, fell on average in the myo-inositol group and rose slightly in the placebo group (P=.048).
Glucose tolerance test results were lower with myo-inositol at fasting (P=.001), 1 hour (P=.002) and 2 hours (P<.001).
Most clinical outcomes were similar among finishers. Gestational hypertension occurred in 0 of 97 versus 6 of 104 (P=.02), and newborn intensive care transfer in 0 versus 5 (P=.03).

Interpretation

This trial gave obese pregnant women myo-inositol or placebo starting at 12-13 weeks. Myo-inositol was linked with less gestational diabetes and lower insulin resistance. The findings support larger studies of myo-inositol in this group.

RRM Context

Obesity raises insulin resistance. Insulin resistance is a root driver of gestational diabetes. Some obese women also have PCOS, now also called PMOS (polyendocrine metabolic ovarian syndrome). Their cells may handle inositol poorly. Restorative reproductive medicine looks for the root cause behind a pregnancy complication, early. This finding links a nutrient to insulin handling in pregnancy, fitting that same goal: find the metabolic root, and act on it early.

Our editorial summary of this paper, not the article's abstract.

Abstract

Objective

To evaluate whether myo-inositol supplementation, an insulin sensitizer, reduces the rate of gestational diabetes mellitus (GDM) and lowers insulin resistance in obese pregnant women.

Methods

In an open-label, randomized trial, myo-inositol (2 g plus 200 micrograms folic acid twice a day) or placebo (200 micrograms folic acid twice a day) was administered from the first trimester to delivery in pregnant obese women (prepregnancy body mass index 30 or greater. We calculated that 101 women in each arm would be required to demonstrate a 65% GDM reduction in the myo-inositol group with a statistical power of 80% (α=0.05). The primary outcomes were the incidence of GDM and the change in insulin resistance from enrollment until the diagnostic oral glucose tolerance test.

Results

From January 2011 to April 2014, 220 pregnant women at 12-13 weeks of gestation were randomized at two Italian university hospitals, 110 to myo-inositol and 110 to placebo. Most characteristics were similar between groups. The GDM rate was significantly reduced in the myo-inositol group compared with the control group, 14.0% compared with 33.6%, respectively (P=.001; odds ratio 0.34, 95% confidence interval 0.17-0.68). Furthermore, women treated with myo-inositol showed a significantly greater reduction in the homeostasis model assessment of insulin resistance compared with the control group, -1.0±3.1 compared with 0.1±1.8 (P=.048).

Conclusion

Myo-inositol supplementation, started in the first trimester, in obese pregnant women seems to reduce the incidence in GDM through a reduction of insulin resistance.

Trial Registration

ClinicalTrials.gov, www.clinicaltrials.gov, NCT01047982.

Topics

Therapeutics › Metabolic and Endocrine Agents › Insulin Sensitizing Agents · Lifestyle and Environment › Nutrition and Metabolic Health › Blood Sugar and Insulin

Antonino DI Benedetto, Angelo Santamaria, Elisabetta Petrella, Isabella Neri, Basilio Pintaudi, Francesco Corrado, Fabio Facchinetti, Rosario D'Anna, Maria Lieta Interdonato, Angela Scilipoti

A Benedetto, A Santamaria, E Petrella, I Neri, B Pintaudi, F Corrado, F Facchinetti, R D'Anna, M Interdonato, A Scilipoti

PMID 26241420 26241420 DOI 10.1097/AOG.0000000000000958 10.1097/AOG.0000000000000958 D'Anna et al. 2015, D'Anna 2015

Keywords

Blood Glucose, Vitamin B Complex, Inositol