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

Women's Hospital School Of Medicine Zhejiang University

Status: Completed

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: D-chiro inositol

Study type: Interventional

Funder types: Other

Identifiers

NCT04801485

IRB-20190035-R

Details and patient eligibility

About

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.

Enrollment: 291 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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291 participants in 2 patient groups, including a placebo group

D-chiro inositol

Active Comparator group

Description:

500 mg twice a day

Treatment:

Dietary Supplement: D-chiro inositol

Placebo

Placebo Comparator group

Description:

500 mg twice a day

Treatment:

Dietary Supplement: Placebo