The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects

Not Applicable

• Conditions: Obesity; Healthy
• Interventions: Behavioral: Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction); Behavioral: Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet; Behavioral: Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).

• Registration Number: NCT00700245
• Lead Sponsor: Aarhus University Hospital

Brief Summary

The human adipose and muscle -tissue produce and release a number of bioactive proteins which contributes to the chronic low grade of inflammatory status which is associated with obesity and plays an important role in the pathogenesis of type 2 diabetes and cardiovascular diseases.

Study 1: Our aim is to investigate if exercise has independent and additive effects in combination with diet-induced weight loss on circulating levels of inflammatory markers and mRNA levels in subcutaneous adipose tissue (SAT) and skeletal muscle tissue (SM.

Study 2: Our aim is to investigate whether gender and weight status plays a role in the metabolic response during two hours of acute exercise

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Status Verified: 2008-06
• Primary Completion: 2008-06
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Last Update Submitted: 2008-06-17
• Study First Posted: 2008-06-18
• Last Update Posted: 2008-06-18
• Study Completion: 2009-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age 18-45 years,
• obese (30 kg/m2 < BMI < 40 kg/m2) physically inactive (<30 minutes pr. day)
• and weight stabile for at least three months (± 2 kg of current body weight)

Exclusion Criteria

• cardiovascular disease,
• type 2 diabetes, pregnancy or orthopaedic difficulties causing inability to undertake an exercise program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EXO	Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction)	Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction),
DIO	Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet	Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet)
DEX	Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).	Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks).

Primary Outcome Measures

Name	Time	Method
Changes in inflammatory markers as Adiponectin, MCP-1, Interleukin-6 and CRP. Moreover changes in body composition quantified with MRI	8 weeks and 12 weeks
Change in Interleukin-6 and other inflammatory markers in plasma, adipose tissue and muscle tissue	60, 120 240 minutes

Trial Locations

Locations (1)

Department of Medicine and Endocrinology C; 🇩🇰 Aarhus, Denmark