This trial is active, not recruiting.

Condition obesity
Treatments general lifestyle, diet and physical activity counselling, exercise training
Sponsor Hospital de Clinicas de Porto Alegre
Start date February 2009
End date March 2012
Trial size 50 participants
Trial identifier NCT00929890, 08282


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
(Active Comparator)
Patients will receive dietary counseling and a general advice on physical activity
general lifestyle, diet and physical activity counselling
Low-calorie, balanced diet and a general advice on the importance of regular physical activity
patients will receive dietary counseling and will be enrolled in supervised exercise training
exercise training
Subject will receive dietary counselling (low-calorie, balanced diet) and will be enrolled in a supervised, 3 times a week, exercise training program

Primary Outcomes

Reduction in homeostasis model assessment of insulin resistance (HOMA-IR)
time frame: 6 months
Change in lipid profile
time frame: 6 months
Reduction in abdominal (visceral) fat
time frame: 6 months
Change in vascular reactivity
time frame: 6 months

Secondary Outcomes

C-reactive protein
time frame: 6 months
time frame: 6 months
vonWillebrand factor
time frame: 6 months
Waist circumference
time frame: 6 months

Eligibility Criteria

Male or female participants from 20 years up to 45 years old.

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

Additional Information

Official title Effect of Weight Loss Through Dietary Energy Restriction With or Without Exercise on Vascular and Metabolic Parameters in Subjects With Obesity
Principal investigator Rogério Friedman, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre.