Impact of Intermittent Fasting on the Incidence of Gestational Diabetes Mellitus(DM) in Obese Pregnant Women in 3rd Trimester
试验速览
- 阶段
- 不适用
- 入组人数
- 252
- 主要终点
- gestational diabetes
研究概览
简要总结
This randomized controlled clinical trial will assess the impact of intermittent fasting on the incidence of gestational DM in obese pregnant women in 3rd trimester and its effect on maternal and neonatal outcomes.
详细描述
The term intermittent fasting, when used for health reasons or weight loss, has been used to describe various types of caloric restriction. Some authors use it when a patient withholds caloric intake for several consecutive hours during the day (often 16 h with all energy intake during the other 8 h of the day, others for a full day once or twice a week , and others three or four days per week Some protocols allow protein intake but no carbohydrates and still label it intermittent fasting.
Others allow carbohydrates or macro/micro-nutrients up to a limit that will still promote ketosis and, although it is simply a low-calorie diet, due to the popularity of fasting this has been labeled a diet that mimics fasting.
In this protocol we use 16hour fasting in 24hour with the same caloric intake in 8hour and can drink water ,coffee , and other noncaloric beverages during the fast, which can help reduce feelings of hunger .
In all instances, non-caloric fluid intake is permitted (which is one of the main differences when compared to religious fasting) and therefore significantly reduces the risk of dehydration and hypotension, a prominent consideration in religious fasting.
During the fasting hours and after breaking the fast, metabolic condition of the body could be influenced as a consequence of change in the pattern and amount of activity, meals and fluid intake, and even sleeping hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnant women.
- •Age (18 - 35 years old).
- •Women with BMI (_> 30 kg/m2).
- •A living singleton pregnancy. Gestational age (24- 27 weeks).(recruitment time)
排除标准
- •Multiple gestations.
- •Women with diabetes
- •pre-pregnancy cardiovascular disease, chronic hypertensive, and pregnancy-induced hypertension; blood pressure _> 140/
- •Women with hepatic, renal diseases or coagulopathy
- •Women with peptic ulcer.
结局指标
主要结局
gestational diabetes
时间窗: from 24-36 weeks of gestation
percentage of diabetes in obese patient is increased by 1.3% and it will be assessed by glucose tolerance test
次要结局
- Maternal weight gain,(from 24-36 weeks of gestation)
- Fetal weight(on labour)
- fetal Apgar score(on labour)
- NICU(neonatal intensive care unit) admission(on labour)
- mode of delivery(on 36 weeks of gestation)
- any associated comorbidities questionnaires(from 24-36 weeks of gestation)