DRKS00032036招募中Unknown
Safety and efficacy of intermittent fasting and exercise in overweight people with type 2 diabetes – a randomized controlled trial - InterFast 3
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •(1) Age between 18 and 75 years, both inclusive
- •(2) Informed consent has to be given in written form
- •(3) Body Mass Index >27.0 kg/m2
- •(4) Glycated haemoglobin levels HbA1c =7.0% (=53mmol/mol) and =10.0% (=86mmol/mol); Point of care measurements or HbA1c measurement within the last 4 weeks are acceptable
- •(5) Stable body weight for preceding 3 months (< 3kg increase or decrease)
- •(6) Able and willing to safely comply with study procedures
- •(7) Be able to attend the study site and willing to participate in necessary protocols
- •(8) Be willing to undertake the durations of fasting required by the study
排除标准
- •(1) Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
- •(2) Continuous treatment with insulin
- •(3) Therapy with sulfonylurea
- •(4) Active known malignancy within the last year excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma
- •(5) Pregnancy or intention of becoming pregnant; breastfeeding
- •(6) History of any chronic disease process that could interfere with interpretation of study results
- •(7) New hormonal supplementation or contraceptive hormonal medication for less than 2 months
- •(8) Acute or chronic inflammatory disorder
- •(9) Alcohol abuse (more than 15 drinks / week)
- •(10) Currently perform overnight shift work
- •(11) Intake of illicit substances
- •(12) Subjects with previous or present history of eating disorders
- •(13) Subject has participated in another study of an investigational medication or an investigational medical device within the last 30 days or is currently participating in these studies
- •(14) Clinically significant abnormal ECG at screening, as judged by the Investigator
- •(15) Conditions that prevent people from following the exercise programme
- •(16) Acute coronary syndrome or stroke within the last 6 months
研究者
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