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

Not Applicable

• Conditions: Obesity
• Interventions: Behavioral: General lifestyle, diet and physical activity counselling; Behavioral: Exercise training

• Registration Number: NCT00929890
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Status Verified: 2011-07
• Last Update Submitted: 2011-10-25
• Last Update Posted: 2011-10-26
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	General lifestyle, diet and physical activity counselling	Patients will receive dietary counseling and a general advice on physical activity
Exercise training	Exercise training	patients will receive dietary counseling and will be enrolled in supervised exercise training

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
C-reactive protein	6 months
Fibrinogen	6 months
vonWillebrand factor	6 months
Waist circumference	6 months

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil