Effects of Time-restricted Eating on the Incidence of Gestational Diabetes Mellitus in High-risk Populations: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- The incidence of GDM
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18-50 years;
- •The risk for GDM includes overweight or obesity (BMI ≥ 28 kg/m2 before pregnancy), first-degree relative with diabetes, history of cardiovascular disease, hypertension (≥130/80 mmHg or on therapy for hypertension), HDL cholesterol level < 1 mmol/L and/or a triglyceride level > 2.8 mmol/L, history of GDM, history of macrosomia delivery, individuals with polycystic ovary syndrome, repeated positive fasting urine glucose in the first trimester, or age>45 years according to Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022);
- •Less than 14 weeks of gestation;
- •Able to read and complete questionnaires in Chinese;
- •singleton pregnancy.
排除标准
- •Pregestational diabetes (including diabetes diagnosed before conception; fasting blood glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the first trimester; typical symptoms of hyperglycemia or hyperglycemic crisis with optional blood glucose ≥ 11.1 mmol/L);
- •Impaired glucose tolerance (including fasting blood glucose ≥ 5.6 mmol/L or two fasting blood glucose ≥ 5.1 mmol/L in the first trimester);
- •Current or recent use of drugs that affect glucose metabolism such as metformin, glucocorticoids and Orlistat;
- •Severe comorbidities (including cardiac diseases, kidney diseases, hepatopathy, autoimmune diseases, uncontrolled thyroid disease, previous or current malignant tumors, etc.);
- •Fetal malformations or chromosomal abnormalities;
- •Cervical insufficiency (including ultrasonic cervical length < 25 mm before 24 weeks of gestation, history of spontaneous preterm birth at 14-36 weeks of previous pregnancy, or cervical dilation in the past or current pregnancy);
- •Exercise contraindications (including continuous vaginal bleeding, threatened premature labor, placenta previa, premature rupture of membranes, severe anemia, etc.);
- •Drug abuse, which refers to the repetitive, heavy use of drugs with dependent characteristics such as narcotic, psychotropic substances, tobacco and alcohol;
- •Hyperemesis gravidarum, which refers to the severe and persistent nausea and vomiting, unable to eat or eat little that leads to dehydration, ketosis and even acidosis;
- •On a special or prescribed diet for other reasons;
- •Eating window<10 h；
- •Considered by the researchers to be ineligible for participation.
- •Exit criteria：
- •Failure to comply with or assume the corresponding responsibilities and obligations of the informed agreement;
- •Pregnant women who terminate their pregnancy before completing GDM diagnosis and screening at 24-28 weeks of pregnancy will automatically withdraw from the group, such as severe fetal malformation, eclampsia, abortion, etc.
- •Major diseases, such as particularly serious obstetric medical events, malignant tumors, serious cardiovascular and cerebrovascular diseases, brain injuries, paralysis and other major diseases, can not continue to accept this intervention plan and follow-up, and withdraw from the study;
- •Accidental disability or death caused by non-intervention factors occurred during the study period, and he withdrew from the study;
- •Subjects are subjectively unwilling to continue to accept the intervention program, and sign the withdrawal agreement to withdraw from the group on a voluntary basis, and decide whether to continue to follow up the pregnancy process and outcome according to the specific contents of the withdrawal statement.
研究组 & 干预措施
TRE(Time-restricted eating group)
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).
干预措施: Time-limited eating (Behavioral)
SOC (standard of care group)
Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months.
结局指标
主要结局
The incidence of GDM
时间窗: 26 gestational weeks
Diagnosed by the 75g oral glucose tolerance test (OGTT).
次要结局
- 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)
研究者
Yu Xiong
Clinical Professor
Obstetrics & Gynecology Hospital of Fudan University