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

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus in Pregnancy

• Registration Number: NCT04801485
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-14
• Study First Posted: 2021-03-17
• Primary Completion: 2022-11-30
• Study Completion: 2023-05-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 291

Inclusion Criteria

• During 12-16 weeks gestation
• Meet any of the following: prepregnancy BMI > 24, family history of diabetes (type 1 or 2), GDM history, history of delivering macrosomia, gestational history of stillbirth;
• Willing to participate

Exclusion Criteria

• Type 1 or type 2 diabetes mellitus diagnosed before pregnancy
• Multiple gestation
• Mental or cognitive impairment cannot complete the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the incidence of gestational diabetes	24-28th weeks gestation	The number of cases and incidence of gestational diabetes according to OGTT

Secondary Outcome Measures

Name	Time	Method
the perinatal outcomes-2	Delivery	weight gain during pregnancy (kg)
the perinatal outcomes-3	Delivery	the Caesarean-section incidence (%)
the perinatal outcomes-1	Delivery	the incidence of macrosomia (macrosomia refers to a newborn weighs more than 4 kg)

Trial Locations

Locations (1)

Xinning Chen; 🇨🇳 Hangzhou, Zhejiang, China