Gestational Diabetes Mellitus in Pregnancy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTD-chiro inositol
Active group receives inositol 1 gram per day as well as health guidance about diet and exercise. From recruitment until OGTT.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Quzhou Maternal and Child Health Care Hospital
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of gestational diabetes | 24-28th weeks gestation | The number of cases and incidence of gestational diabetes according to OGTT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
Countries
China
Outcome results
None listed