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

June 29, 2009
October 25, 2011
February 2009
March 2012   (final data collection date for primary outcome measure)
  • 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 ]
Reduction in HOMA-IR Change in lipid profile Reduction in abdominal (visceral) fat Change in vascular reactivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00929890 on ClinicalTrials.gov Archive Site
  • 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 ]
C-reactive protein fibrinogen vonWillebrand factor waist circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Additional Metabolic and Vascular Effects of Exercise in Patients on Diet-based Weight Loss Programs
Effect of Weight Loss Through Dietary Energy Restriction With or Without Exercise on Vascular and Metabolic Parameters in Subjects With Obesity

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Obesity
  • Behavioral: General lifestyle, diet and physical activity counselling
    Low-calorie, balanced diet and a general advice on the importance of regular physical activity
  • 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
  • Active Comparator: Lifestyle counseling
    Patients will receive dietary counseling and a general advice on physical activity
    Intervention: Behavioral: General lifestyle, diet and physical activity counselling
  • Experimental: Exercise training
    patients will receive dietary counseling and will be enrolled in supervised exercise training
    Intervention: Behavioral: Exercise training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00929890
08282
No
Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Not Provided
Principal Investigator: Rogério Friedman, MD, PhD Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP