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.

Not Applicable

• Conditions: E66.0; R73.0; Obesity due to excess calories; Abnormal glucose tolerance test

• Registration Number: DRKS00006811
• Lead Sponsor: Inst, f. Sport u. Sportwisenschaftder Universität Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-14
• Study Completion: 2017-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 463

Inclusion Criteria

• 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.

Exclusion Criteria

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total body weight (pre-start, after 4, 12, 26 and 52 weeks)

Secondary Outcome Measures

Name	Time	Method
body fat and lean body mass (BIA)<br>fasting blood glucose, fasting insulin level and insulin resistance (HOMA), HbA1c, leptin, ApoB (clinical routine methods) (pre-start, after 4, 12, 26 and 52 weeks)