ISRCTN70090382已完成不适用
Effects of a very low calorie diet (VLCD) induced weight loss on obstructive sleep apnoea syndrome (OSAS): a randomised controlled trial
Cambridge Manufacturing Company Limited (UK)0 个研究点目标入组 60 人开始时间: 2009年2月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •Amended as of 09/06/2009:
- •The following points of the below inclusion criteria have been amended:
- •1. Patients with OSAS with an Apnoea-Hypopnea Index (AHI) greater than or equal to 15
- •3. Aged between 30 and 65 years
- •All other inclusion criteria remain unaffected.
- •Initial information at time of registration:
- •1. Patients with OSAS with an Apnoea-Hypopnea Index (AHI) between 15 and 60
- •2. Male patients
- •3. Age between 30 and 60 years
- •4. Abdominal obesity with a Body Mass Index (BMI) 30-40 kg/m^2 and waist circumference >102 cm
- •5. Signed informed consent to participate in the study
排除标准
- •1. Contraindications for VLCD:
- •1.1. Coronary thrombosis or myocardial infarct within the last three months
- •1.2. Cerebro-vascular accident within the last three months
- •1.3. Unstable ventricular arrhythmias
- •1.4. Major surgery or trauma within the last three months
- •1.5. Impaired renal or hepatic function
- •1.6. Severe depression
- •1.7. Use of mono-amine oxidase inhibitors (MAOIs)as anti-depressants
- •1.8. Anorexia nervosa or bulimia nervosa
- •1.9. Porphyria
- •1.10. Milk protein allergy (the diet is milk based)
- •1.11. Severe lactose intolerance (the diet is milk based)
- •1.12. (Pregnant and lactating women, children below the age of 14)
- •2. Drug treated diabetes
- •3. Currently on a weight loss drug (Acomplia®, Reductil® or Xenical®)
- •4. Bariatric surgery
- •5. Recent angina pectoris or atrial fibrillation
研究者
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