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

Study Overview
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Brief Summary
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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

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

Conditions
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Obesity, Healthy

Intervention / Treatment
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* 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).


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EXO<br>Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction), | Behavioral: Exercise-only (EXO-12 weeks of regular supervised exercise without diet restriction)<br>* The exercise intervention for subjects in the EXO consisted of supervised aerobic exercise three times per week with a duration of 60 -75 minutes pr. training session, with an estimated energy expenditure of 500-600 kcal per session. The subjects could choose between different modes of exercise; stationary bicycling, jogging on a treadmill or stair stepping.<br>|
| Active Comparator: DIO<br>Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet) | Behavioral: Diet-only (DIO-8 weeks of very low energy diet (VLED 600 kcal/d) followed by 4 weeks weight maintenance diet<br>* Subjects in the DIO group were prescribed a liquid VLED(Nupo, Copenhagen) of respectively 600 and 800 kcal pr. day (proteins 41 g, carbohydrates 29 g, fat 5.6 g. pr 100 gram) for eight weeks followed by a weight maintenance diet for four weeks.<br>|
| Active Comparator: DEX<br>Diet+exercise (DEX-8 weeks VLED 800 kcal/d + a four weeks weight maintenance diet combined with regular supervised exercise throughout the 12 weeks). | 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).<br>* The exercise intervention for subjects in the DEX group consisted of supervised aerobic exercise three times per week with a duration of 60 -75 minutes pr. training session, with an estimated energy expenditure of 500-600 kcal per session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obese, Adults