Efficacy of myoinositol in treatment of gestational diabetes mellitus in Asian Indian women: A pilot randomized clinical trial.

Abstract

OBJECTIVE\nTo compare efficacy of myoinositol as an adjuvant to dietary modification for treatment of gestational diabetes mellitus in Asian Indian women compared to controls.\n\n\nSTUDY DESIGN\nSetting: This pilot randomized open label trial was conducted in a single antenatal clinic in India.\n\n\nSUBJECTS\nOne hundred women with singleton pregnancy and gestational diabetes diagnosed between 14-28 weeks gestation were included. Overt diabetes, twin pregnancy, pre-existing renal disease, heart disease and other chronic medical disorders were exclusions.\n\n\nINTERVENTION\nParticipants were randomized in two groups (1:1 ratio) by opaque envelope method. Individualized nutrition counseling with dietary modification and routine antenatal care was provided to all. Fifty women received myoinositol 1000 mg twice daily; 50 controls did not receive myoinositol. Fasting and postprandial glucose levels were assessed after two weeks. Women not achieving glycemic targets (fasting glucose <95 and postprandial glucose <120 mg/dL) were given pharmacologic therapy. Contributory factors in women requiring additional pharmacologic therapy, maternal and fetal outcomes were noted.\n\n\nSTATISTICAL ANALYSIS\nBetween group comparisons reported relative risk and mean difference. To assess predictive factors for need for pharmacologic therapy, univariate and multivariable logistic regression analysis were used.\n\n\nRESULTS\nBaseline characteristics were comparable in both groups. Except one woman in the myoinositol group, all women provided glycaemia data throughout their pregnancy. Glycemic control was achieved in 44/ 49 (89.8 %) women in myoinositol group which was significantly higher than 34/50 (68 %) in the controls ((relative risk 0.31, 95 % confidence interval 0.13 to 0.80, p = 0.008). Mean duration of myoinositol treatment was 17.6 weeks (standard deviation 5.3). Additional treatment with metformin/insulin was needed in all women failing to achieve glycaemic control. The mean (range) dose of insulin was 25.3 units in myoinositol group compared to 14.27 units in controls (p = 0.058). Secondary outcomes were similar in two groups except baby weight which was higher in controls (p = 0.018).\n\n\nCONCLUSIONS\nOral supplementation with myoinositol in dose of 1 gm twice-daily, when started soon after the diagnosis of GDM, is effective in achieving glycemic control and decreasing the need for additional pharmacological therapy in Asian Indian women.