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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04801485 on ClinicalTrials.gov