Obesity Clinical Trial
Official title:
Effect of Weight Loss Through Dietary Energy Restriction With or Without Exercise on Vascular and Metabolic Parameters in Subjects With Obesity
This study tests the hypothesis that exercise training can confer additional benefit to patients in weight-loss programs in the form of improvements in either metabolic or vascular parameters or both. Patients will be randomized to either diet plus conventional physical activity or diet plus a planned exercise training. The interventions will be carried out until the patients lose between 5% and 7.5% of their initial weight. At entry and at the end, all subjects will be evaluated for outcomes such as blood glucose, lipid profile, insulin, c-reactive protein, fibrinogen, vascular reactivity (doppler ultrasound) and total and abdominal visceral fat (CT-scan). Both groups will be compared.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion Criteria: - BMI> 30 and <40 Exclusion Criteria: - Diabetes mellitus - Active endocrine disease - Active heart disease - Active smoking - Medical contra-indications for exercise - Using anti-obesity drugs |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in homeostasis model assessment of insulin resistance (HOMA-IR) | 6 months | No | |
Primary | Change in lipid profile | 6 months | No | |
Primary | Reduction in abdominal (visceral) fat | 6 months | No | |
Primary | Change in vascular reactivity | 6 months | No | |
Secondary | C-reactive protein | 6 months | No | |
Secondary | Fibrinogen | 6 months | No | |
Secondary | vonWillebrand factor | 6 months | No | |
Secondary | Waist circumference | 6 months | No |
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