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临床试验/DRKS00006811
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

研究者

发起方
Inst, f. Sport u. Sportwisenschaftder Universität Freiburg

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