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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Gestational Diabetes Mellitus in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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D-chiro inositol

500 mg twice a day

Group Type ACTIVE_COMPARATOR

D-chiro inositol

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

500 mg twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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D-chiro inositol

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

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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