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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014