Myo-inositol in Prevention of Gestational Diabetes Mellitus in China

Sponsor

Women's Hospital School Of Medicine Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04801485

Collaborator

Quzhou Maternal and Child Health Care Hospital (Other)

360

Enrollment

Location

Arms

Anticipated Duration (Months)

21.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Myo-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 2 g of myo-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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes Mellitus in Pregnancy	Dietary Supplement: Myo-inositol Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

Myo-inositol in Prevention of Gestational Diabetes Mellitus in High Risk Pregnant Women in China

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Myo-inositol	Dietary Supplement: Myo-inositol Active group receives myo-inositol 1 gram per day as well as health guidance about diet and exercise. From recruitment until OGTT.
Placebo Comparator: Placebo	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.

Arm

Intervention/Treatment

Active Comparator: Myo-inositol

Dietary Supplement: Myo-inositol

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

Placebo Comparator: Placebo

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.

Outcome Measures

Primary Outcome Measures

the incidence of gestational diabetes [24-28th weeks gestation]
The number of cases and incidence of gestational diabetes according to OGTT

Secondary Outcome Measures

the perinatal outcomes-1 [Delivery]
the incidence of macrosomia (macrosomia refers to a newborn weighs more than 4 kg)
the perinatal outcomes-2 [Delivery]
weight gain during pregnancy (kg)
the perinatal outcomes-3 [Delivery]
the Caesarean-section incidence (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinning Chen	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol - Feb 4, 2021

More Information

Publications

None provided.

Responsible Party:

Women's Hospital School Of Medicine Zhejiang University

ClinicalTrials.gov Identifier:

NCT04801485

Other Study ID Numbers:

IRB-20190035-R

First Posted:

Mar 17, 2021

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes, Gestational

Pregnancy in Diabetics

Diabetes Mellitus

Inositol

Study Results

No Results Posted as of Mar 17, 2021