The Prevention of Gestational Diabetes Mellitus With Antenatal Oral Inositol Supplementation: A Randomized Controlled Trial

Diabetes Care
Q1
Mar 2017
Citations:65
Influential Citations:8
Interventional (Human) Studies
97
S2 IconPDF Icon

Enhanced Details

Methods
Single-center open-label randomized controlled trial at Coombe Women & Infants University Hospital, Dublin; pregnant women with a family history of diabetes; enrolled at first antenatal visit (10–16 weeks); 240 participants (120 per group); mean age 31.3 years; mean BMI 26.1 kg/m2; 16% obese; 33% nulliparous; exclusions: <18 years, multiple pregnancy, limited English, pre-existing liver/kidney disease, diabetes; randomization by independent statistician using sealed envelopes; intention-to-treat analysis; primary outcome: incidence of gestational diabetes diagnosed by 75-g OGTT between 24–28 weeks (IADPSG).
Intervention
Daily oral combination started at the first antenatal visit (10–16 weeks gestation) and continued until delivery; 1,100 mg myo-inositol + 27.6 mg D-chiro-inositol + 400 mg folic acid per day.
Results
GDM incidence was 23.3% (n=28) in the intervention group vs 18.3% (n=22) in the control group (P=0.34). Mean fasting OGTT glucose was 81 mg/dL in both groups; 1‑h OGTT 138.4 mg/dL vs 133.2 mg/dL (P=0.42); 2‑h OGTT 102.6 mg/dL vs 97.2 mg/dL (P=0.07). Starting the inositol combination early in pregnancy did not prevent GDM in women with a family history of diabetes; authors suggest evaluating different doses in future studies.
Limitations
Open-label design; single-center; study powered to detect a 50% reduction (may miss smaller effects); potential biases due to lack of blinding; generalizability may be limited.

Abstract

OBJECTIVE This study investigated if inositol in a combination of myo-inositol and D-chiro-inositol would prevent gestational diabetes mellitus (GDM) in women with a family history of diabetes. RESEARCH DESIGN AND METHODS This was a randomized contro...