NCT04452968已完成不适用
Intermittent Fasting and Polycystic Ovarian Syndrome
Karachi Medical and Dental College2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2020年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- weight loss in kg
研究概览
简要总结
Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that avoids major dietary changes but achieves strong effects. It also improves insulin sensitivity through increased human growth hormone. This effect helps to improve the root cause of weight gain and has additional benefits for women with PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS as described by Rotterdam's criteria
排除标准
- •endocrine disorders
- •hypertensive
- •Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
- •The body weight fluctuated more than 5% in recent 3 months.
- •Liver and kidney dysfunction: renal impairment, creatinine clearance rate < 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit;
- •History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
- •History of thyroid diseases;
- •Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight)
- •Patients who cannot be followed for 16 months (due to a health situation or migration)
- •Patients who are unwilling or unable to give informed consent
结局指标
主要结局
weight loss in kg
时间窗: in 3 months
次要结局
- decrease in body fat percentage(in 3 months)
- blood pressure in mm Hg(in 3 months)
- fasting plasma insulin(in 3 months)
研究者
samia husain
clinical investigator
Karachi Medical and Dental College
研究点 (2)
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