Additional Metabolic and Vascular Effects of Exercise in Patients on Diet-based Weight Loss Programs

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Weight Loss Through Dietary Energy Restriction With or Without Exercise on Vascular and Metabolic Parameters in Subjects With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: General lifestyle, diet and physical activity counselling
* Behavioral: Exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle counseling<br>Patients will receive dietary counseling and a general advice on physical activity | Behavioral: General lifestyle, diet and physical activity counselling<br>* Low-calorie, balanced diet and a general advice on the importance of regular physical activity<br>|
| Experimental: Exercise training<br>patients will receive dietary counseling and will be enrolled in supervised exercise training | Behavioral: Exercise training<br>* Subject will receive dietary counselling (low-calorie, balanced diet) and will be enrolled in a supervised, 3 times a week, exercise training program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in homeostasis model assessment of insulin resistance (HOMA-IR) |  | 6 months | 
| Change in lipid profile |  | 6 months | 
| Reduction in abdominal (visceral) fat |  | 6 months | 
| Change in vascular reactivity |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein |  | 6 months | 
| Fibrinogen |  | 6 months | 
| vonWillebrand factor |  | 6 months | 
| Waist circumference |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Exercise, Diet, Lifestyle, Vascular reactivity, Body composition, Lipids, Glucose, Insulin resistance