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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00929890
• Other study ID #: 08282
• Status: Active, not recruiting
• Phase: N/A
• First received: June 29, 2009
• Last updated: October 25, 2011
• Start date: February 2009
• Est. completion date: March 2012

Study information

• Verified date: July 2011
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Comissão Nacional de Ética em Pesquisa
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• General lifestyle, diet and physical activity counselling
Low-calorie, balanced diet and a general advice on the importance of regular physical activity
• 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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

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