NCT04801485

D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in China

D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in High Risk Pregnant Women in China

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Inositol is a type of food additives, which plays an important role in insulin signal pathway and is related to insulin sensitivity. Our randomized, double-centered, placebo-controlled study is planned to recruit 360 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly 1 g of D-chiro inositol per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about delivery time, neonatal weight will be registered.

Conditions

• Gestational Diabetes Mellitus in Pregnancy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	D-chiro inositol	Active group receives inositol 1 gram per day as well as health guidance about diet and exercise. From recruitment until OGTT.
DIETARY_SUPPLEMENT	Placebo	Placebo (similar appearance but not containing myo-inositol) 1 gram per day before meals. Similar health guidance about diet and exercise. From recruitment until OGTT.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-11-30
• Completion: 2023-05-01
• First posted: 2021-03-17
• Last updated: 2025-04-17

Locations

1 site across 1 country: China