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

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ClinicalTrials.gov Identifier: NCT00929890
Recruitment Status : Unknown
Verified July 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Active, not recruiting
First Posted : June 30, 2009
Last Update Posted : October 26, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity Behavioral: General lifestyle, diet and physical activity counselling Behavioral: Exercise training

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effect of Weight Loss Through Dietary Energy Restriction With or Without Exercise on Vascular and Metabolic Parameters in Subjects With Obesity
Study Start Date : February 2009
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Lifestyle counseling
Patients will receive dietary counseling and a general advice on physical activity
Behavioral: General lifestyle, diet and physical activity counselling
Low-calorie, balanced diet and a general advice on the importance of regular physical activity
Experimental: Exercise training
patients will receive dietary counseling and will be enrolled in supervised exercise training
Behavioral: 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


Outcome Measures

Primary Outcome Measures :
  1. Reduction in homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: 6 months ]
  2. Change in lipid profile [ Time Frame: 6 months ]
  3. Reduction in abdominal (visceral) fat [ Time Frame: 6 months ]
  4. Change in vascular reactivity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. C-reactive protein [ Time Frame: 6 months ]
  2. Fibrinogen [ Time Frame: 6 months ]
  3. vonWillebrand factor [ Time Frame: 6 months ]
  4. Waist circumference [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929890


Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Rogério Friedman, MD, PhD Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
More Information

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00929890     History of Changes
Other Study ID Numbers: 08282
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: July 2011

Keywords provided by Hospital de Clinicas de Porto Alegre:
Obesity
Exercise
Diet
Lifestyle
Vascular reactivity
Body composition
Lipids
Glucose
Insulin resistance

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes