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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle counseling | Active Comparator | Patients will receive dietary counseling and a general advice on physical activity |
|
| Exercise training | Experimental | patients will receive dietary counseling and will be enrolled in supervised exercise training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General lifestyle, diet and physical activity counselling | Behavioral | Low-calorie, balanced diet and a general advice on the importance of regular physical activity |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein | 6 months | |
| Fibrinogen | 6 months | |
| vonWillebrand factor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rogério Friedman, MD, PhD | Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33487260 | Derived | Lopes AL, Macedo RCO, Kruger RL, Friedman R, Carteri RB, Reischak-Oliveira A. Fasted exercise does not improve postprandial lipemia responses to different meals in lean and obese subjects: A crossover, randomized clinical trial. Clin Nutr ESPEN. 2021 Feb;41:160-167. doi: 10.1016/j.clnesp.2020.11.013. Epub 2020 Dec 30. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
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| Exercise training | Behavioral | Subject will receive dietary counselling (low-calorie, balanced diet) and will be enrolled in a supervised, 3 times a week, exercise training program |
|
| 6 months |
| Waist circumference | 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |