D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in China
Primary Purpose
Gestational Diabetes Mellitus in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
D-chiro inositol
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes Mellitus in Pregnancy
Eligibility Criteria
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
Sites / Locations
- Xinning Chen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
D-chiro inositol
Placebo
Arm Description
500 mg twice a day
500 mg twice a day
Outcomes
Primary Outcome Measures
the incidence of gestational diabetes
The number of cases and incidence of gestational diabetes according to OGTT
Secondary Outcome Measures
the perinatal outcomes-1
the incidence of macrosomia (macrosomia refers to a newborn weighs more than 4 kg)
the perinatal outcomes-2
weight gain during pregnancy (kg)
the perinatal outcomes-3
the Caesarean-section incidence (%)
Full Information
NCT ID
NCT04801485
First Posted
March 4, 2021
Last Updated
July 1, 2023
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Quzhou Maternal and Child Health Care Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04801485
Brief Title
D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in China
Official Title
D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in High Risk Pregnant Women in China
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
May 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Quzhou Maternal and Child Health Care Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
291 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D-chiro inositol
Arm Type
Active Comparator
Arm Description
500 mg twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500 mg twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
D-chiro inositol
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of gestational diabetes
Description
The number of cases and incidence of gestational diabetes according to OGTT
Time Frame
24-28th weeks gestation
Secondary Outcome Measure Information:
Title
the perinatal outcomes-1
Description
the incidence of macrosomia (macrosomia refers to a newborn weighs more than 4 kg)
Time Frame
Delivery
Title
the perinatal outcomes-2
Description
weight gain during pregnancy (kg)
Time Frame
Delivery
Title
the perinatal outcomes-3
Description
the Caesarean-section incidence (%)
Time Frame
Delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Xinning Chen
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
12. IPD Sharing Statement
Learn more about this trial
D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in China
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