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

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04801485
• Other study ID #: IRB-20190035-R
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: July 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: May 1, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

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
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.

Locations

Country	Name	City	State
China	Xinning Chen	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University	Quzhou Maternal and Child Health Care Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of gestational diabetes	The number of cases and incidence of gestational diabetes according to OGTT	24-28th weeks gestation
Secondary	the perinatal outcomes-1	the incidence of macrosomia (macrosomia refers to a newborn weighs more than 4 kg)	Delivery
Secondary	the perinatal outcomes-2	weight gain during pregnancy (kg)	Delivery
Secondary	the perinatal outcomes-3	the Caesarean-section incidence (%)	Delivery