DRKS00006811已完成未知
The ALMASED Concept against Overweight and Obesity and Related Health Risk (ACOORH),Evaluation of Almased on body composition and co-morbidities in non-diabetic, viscerally fat-distributed overweight or obese patients with at least one additional co-morbidity and with a special focus on the pre-diabetic state. - ACOORH
Inst, f. Sport u. Sportwisenschaftder Universität Freiburg0 个研究点目标入组 463 人开始时间: 2014年10月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 463
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
- 21 Years 至 65 Years(—)
- 性别
- All
入选标准
- •Age: 21-65 years
- •waist circumference = 102cm for males and = 88 cm for females
- •BMI 27-35 kg/m2
- •with at least one additional co-morbidity of the metabolic syndrome:
- •- fasting blood glucose of 100-126 mg/dl
- •- and/or triglycerides of 150-400 mg/dl
- •- and/or low HDL cholesterol (<40 mg/dl)
- •- and/or hypertension (anti-hypertensive therapy or untreated systolic blood pressure of 140-160 and/or diastolic blood pressure of 90-100 mmHg)
- •Willingness to participate: Participants must be willing to be randomized to either Almased or the Lifestyle Intervention and to follow the protocol to which they have been assigned.
排除标准
- •- Inability to be physically moderately active due to illness (e.g., chronic heart disease, arrhythmia or heart rate at rest >100/min, valvular heart disease, arthritis of larger joints, etc.)
- •- Inability to perform physical exercise according to AHA/ACSM criteria
- •- Total body weight > 141 kg
- •- Impaired motor skills and / or load-bearing capacity of the supporting and musculoskeletal system
- •- Severe (rest) hypertension (RRsyst >165 and / or RRdiast >115 mmHg)
- •- Presence of diabetes mellitus type 1
- •- Presence of diabetes mellitus type 2 (HbA1c > 6.5%)
- •- Chronic renal failure (dialysis patient or creatinine >1.4 or 1.5 mg/dL (m/f)
- •- Increasing liver function enzymes (ALT or gamma-GT) by more than threefold
- •- Appetite suppressants, slimming, eating disorder
- •- Psychiatric disorders with permanent medical supervision
- •- Currently pregnant or nursing
- •- Symptoms’ free malignant intervals less than 5 years
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