Effects of Time-restricted Eating on the Incidence of Gestational Diabetes Mellitus in High-risk Populations: a Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes Mellitus
- Sponsor
- Fudan University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- The incidence of GDM
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
This is a randomized controlled trial, aiming to investigate whether a time-restricted eating (TRE) can reduce the incidence of gestational diabetes mellitus (GDM) in high-risk pregnant women. Investigators intend to conduct a 3-month randomized controlled study to compare the effects of 10-hour TRE and habitual eating time on GDM .
Detailed Description
Investigators present a multicenter, open-label and parallel-group randomized study. Total 240 women in early pregnancy were randomly assigned to TRE group and SOC (standard of care) group according to the ratio of 1: 1. Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months. All participants should follow moderate-intensity physical activity for about 30 minutes every day, and receive diet and exercise counseling during the study period. GDM was diagnosed by 75g oral glucose tolerance test (OGTT) test at about 26 gestational weeks.
Investigators
Yu Xiong
Clinical Professor
Obstetrics & Gynecology Hospital of Fudan University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The incidence of GDM
Time Frame: 26 gestational weeks
Diagnosed by the 75g oral glucose tolerance test (OGTT).
Secondary Outcomes
- Number of newborns with macrosomia(At delivery)
- Number of neonatus with hypoglycemia(Within the first 48 hours after delivery)
- Number of newborns with low birth weight(At delivery)
- Number of neonatus with neonatal intensive care unit (NICU) admission(Within the first 28 days after delivery)
- Number of newborns large for gestational age (LGA)(At delivery)
- Number of newborns with birth injury(At delivery)
- Number of neonatus with neonatal respiratory distress(Within the first 28 days after delivery)
- Incidence of shoulder dystocia(At delivery)
- Number of neonatus with pathologic jaundice(Within the first 28 days after delivery)
- Number of neonatus with intraventricular hemorrhage (IVH) of II grade or above(Within the first 28 days after delivery)
- Number of newborns small for gestational age (SGA)(At delivery)
- The incidence of neonatal death.(Within the first 28 days after delivery)
- Maternal change in depression, quality of sleep and quality of life(From pre-pregnancy to 24-28 gestational weeks)
- Number of neonatus with sepsis.(Within the first 28 days after delivery)
- Insulin resistance calculated by homeostatic model assessment (HOMA-IR)(at 24-28 gestational weeks)
- Change in waist circumference(From pre-pregnancy to 24-28 gestational weeks)
- Incidence of maternal morbidities(From 24-28 gestational weeks to delivery)
- Number of neonatus with necrotizing enterocolitis (NEC)(Within the first 28 days after delivery)
- Number of neonatus managed with assisted ventilation >24 hours via endotracheal tube.(Within 72 hours of birth)
- The level of maternal fasting plasma insulin(at 24-28 gestational weeks)
- The level of maternal HbA1c(at 24-28 gestational weeks)
- Maternal lipid profile(at 24-28 gestational weeks)
- Gestational weight gain(From pre-pregnancy to 24-28 gestational weeks)