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Completed

NCT Number: NCT04801485

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Xinning Chen

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-chiro inositol

Dietary Supplement

Active group receives inositol 1 gram per day as well as health guidance about diet and exercise. From recruitment until OGTT.

Placebo

Dietary Supplement

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.

Primary outcomes

  1. the incidence of gestational diabetes

    Time frame: 24-28th weeks gestation

    The number of cases and incidence of gestational diabetes according to OGTT

Secondary outcomes

  1. the perinatal outcomes-1

    Time frame: Delivery

    the incidence of macrosomia (macrosomia refers to a newborn weighs more than 4 kg)

  2. the perinatal outcomes-2

    Time frame: Delivery

    weight gain during pregnancy (kg)

  3. the perinatal outcomes-3

    Time frame: Delivery

    the Caesarean-section incidence (%)

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Collaborators

  • Quzhou Maternal and Child Health Care Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 17, 2021
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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