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| Descriptive Information Fields | |||||||||
| Brief Title † | The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects | ||||||||
| Official Title † | The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects | ||||||||
| 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 |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment | ||||||||
| Primary Outcome Measure † | Changes in inflammatory markers as Adiponectin, MCP-1, Interleukin-6 and CRP. Moreover changes in body composition quantified with MRI [ Time Frame: 8 weeks and 12 weeks ] [ Designated as safety issue: No ] Change in Interleukin-6 and other inflammatory markers in plasma, adipose tissue and muscle tissue [ Time Frame: 60, 120 240 minutes ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | |||||||||
| Condition † | Obesity Healthy |
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| Intervention † | 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). |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 100 | ||||||||
| Start Date † | September 2006 | ||||||||
| Completion Date | March 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | Denmark | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00700245 | ||||||||
| Organization ID | 20060053 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Aarhus University Hospital | ||||||||
| Collaborators †† | |||||||||
| Investigators † | |||||||||
| Information Provided By | Aarhus University Hospital | ||||||||
| Verification Date | June 2008 | ||||||||
| First Received Date † | June 17, 2008 | ||||||||
| Last Updated Date | June 17, 2008 | ||||||||
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