Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00929890
First received: June 29, 2009
Last updated: October 25, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Obesity
 Behavioral: General lifestyle, diet and physical activity counselling
Behavioral: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Reduction in homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reduction in abdominal (visceral) fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in vascular reactivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • C-reactive protein [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fibrinogen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • vonWillebrand factor [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00929890     History of Changes
Other Study ID Numbers: 08282
Study First Received: June 29, 2009
Last Updated: October 25, 2011
Health Authority: Brazil: Comissão Nacional de Ética em Pesquisa

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

ClinicalTrials.gov processed this record on May 19, 2013