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

July 1, 2023 updated by: Women's Hospital School Of Medicine Zhejiang University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Xinning Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: D-chiro inositol
500 mg twice a day
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.
Placebo Comparator: Placebo
500 mg twice a day
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of gestational diabetes
Time Frame: 24-28th weeks gestation
The number of cases and incidence of gestational diabetes according to OGTT
24-28th weeks gestation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Collaborators

Quzhou Maternal and Child Health Care Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 14, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-20190035-R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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