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Testing whether myo-inositol (a nutritional supplement) can reduce diabetes risk in pregnant women

Effect of Myoinositol supplementation in prevention of gestational diabetes mellitus in high risk pregnant women: A Randomized controlled trial in a tertiary care hospital in India . - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109156
Enrollment
164
Registered
2026-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Tab.Myoinositol: Intervention group -Tab.Myoinositol 2 grams twice a day with Tab.Folic acid 200 mcg twice a day orally from 5 to 12 weeks of gestation till 25 weeks of gestation. Co

Sponsors

Endocrinology Society of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Pregnant women aged 18-45 years in the first trimester (between 5 and 12 weeks of gestation) 2)Body mass index (BMI) more than 30kg/m2 3)Family history of type II diabetes 4)Previous history of GDM 5)Polycystic ovary syndrome(PCOS) 6)Body mass index between 23-30kg/m2 7)History of infant macrosomia 8)Singleton gestation

Exclusion criteria

Exclusion criteria: 1)History of diabetes mellitus 2)Multiple pregnancies 3)Acute infections during pregnancies 4)Impaired fasting glucose more than 92 mg/dl, HBA1C more than 5.7 percent 5)Concomitant treatment with corticosteroids 6)Preexisting Hypertension ,Renal and Hepatic disease

Design outcomes

Primary

MeasureTime frame
To assess whether Myoinositol supplementation reduces the incidence of gestational diabetes mellitus (GDM) in high risk pregnant womenTimepoint: 5-12 weeks of gestation(baseline)- fasting blood glucose levels and HBA1C 2)Every 4 weeks-monitor drug compliance and any adverse effects. 3)At 24-28 weeks of gestation oral glucose tolerance test(OGTT) will be done to assess development of Gestational diabetes(GDM).

Secondary

MeasureTime frame
To assess whether Myoinositol supplementation reduces the need for insulin therapy in females who developed Gestational diabetes mellitusTimepoint: every 4 weeks after OGTT till delivery;To assess maternal & fetal complications outcomes in the studyTimepoint: At the time of delivery

Countries

India

Contacts

Public ContactDr.Aishwarya Bora

ESIC Medical College and Hospital Sanathnagar Hyderabad 500038

hariendo@gmail.com9205749354

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026