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

NCT04801485 | Completed

• 1 other identifier: IRB-20190035-R
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• the incidence of gestational diabetes

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

  24-28th weeks gestation

Secondary Outcomes (3)

• the perinatal outcomes-1

  Delivery

• the perinatal outcomes-2

  Delivery

• the perinatal outcomes-3

  Delivery

Study Arms (2)

D-chiro inositol

ACTIVE COMPARATOR

500 mg twice a day

Dietary Supplement: D-chiro inositol

Placebo

PLACEBO COMPARATOR

500 mg twice a day

Dietary Supplement: Placebo

Interventions

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.

D-chiro inositol

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Quzhou Maternal and Child Health Care Hospital: collaborator

Study Sites (1)

Xinning Chen

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Chen X, Du Z, Zhang Z, Chen D. D-Chiro Inositol Supplementation and the Occurrence of Gestational Diabetes: A Randomized Controlled Trial in China. Food Sci Nutr. 2024 Dec 5;13(1):e4601. doi: 10.1002/fsn3.4601. eCollection 2025 Jan.

  PMID: 39803251 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The random number table is compiled by the investigator who is specially responsible for grouping and saved. The investigator packaged and coded drugs according to random number table, and recorded. The packaged and numbered drugs are stored in the enrollment office. When the participants meet the inclusion criteria by care providers (doctors), the enrollment office generates a random number for each subject. The participants received the package of drugs according to their random number, and the random number was recorded in the record book. If there are adverse events or the subjects request to withdraw from the trial, the investigator should uncover the blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 17, 2021
• Study Start: January 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: May 1, 2023
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

CN (1)