NCT01312090已完成不适用
Chronic Intermittent Cold Exposure on Weight Loss
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- weight loss
研究概览
简要总结
- To test whether chronic intermittent cold exposure is more effective in programmed body weight loss when compared to conventional programmed weight loss.
- To measure the metabolic responses (e.g. in the white and brown adipose tissue, muscle and circulating markers) of treatment with chronic intermittent cold exposure and conventional treatment
- To measure tissue specific changes of weight loss and the treatment with chronic intermittent cold exposure in glucose uptake rate in adipose organ (white and brown adipose tissue), liver, myocardium, skeletal muscle and brain
- To measure tissue specific biochemical indicators before and after treatment with chronic intermittent cold exposure from white adipose tissue and skeletal muscle.
- To compare changes in body composition and fat distribution after weight loss using chronic cold exposure or using conventional method
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 30 (inclusive)
- •Body weight less than 120 kg
- •Weight stability for 3 months
- •Plasma triglyceride concentration less than 3.0 mmol/l
- •Plasma HDL-cholesterol more than 0.9 mmol/l in males and more than 1.0 mmol/l in females
- •Blood pressure less than 140/90 mmHg (inclusive)
- •Normal glucose tolerance or impaired glucose tolerance but not diabetes (fasting glucose < 7.0 mmol/l or 2 h glucose in the oral glucose tolerance test < 11.1 mmol/l)
排除标准
- •Frequent weight loss attempts
- •Pregnancy or lactation
- •Diabetes mellitus
- •Hypo/hyperthyreosis
- •Cardiovascular disease, stroke or neurological disorder
- •Medication (antihypertensive and antidiabetic drugs, lipid lowering drugs, antidepressants, corticosteroids)
- •Claustrophobia
- •Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results.
- •Presence of any ferromagnetic objects that would make MRI imaging contraindicated
结局指标
主要结局
weight loss
时间窗: looking forward using periodic observations collected predominantly during 12 months following subject enrollment
Effect of chronic intermittent cold exposure and conventional treatment on weight loss
次要结局
- Glucose uptake(4 months from admission)
- energy metabolism(12 months from admission)
- behavioural patterns(12 months from admission)
- muscle metabolism(12 months from admission)
- white adipose tissue metabolism(12 months from admission)
研究者
Sanna Kaye
MD
Helsinki University Central Hospital
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