D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in China
NCT04801485 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 291
Last updated 2025-04-17
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
- 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.
Sponsors & Collaborators
-
Quzhou Maternal and Child Health Care Hospital
collaborator UNKNOWN -
Women's Hospital School Of Medicine Zhejiang University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-01
- Primary Completion
- 2022-11-30
- Completion
- 2023-05-01
Countries
- China
Study Locations
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