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Impact of Diet and/or Exercise-Induced Weight Loss on Cardiovascular Risk Factors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Yale University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00588978
First received: December 27, 2007
Last updated: January 8, 2008
Last verified: December 2007

December 27, 2007
January 8, 2008
August 2003
February 2007   (final data collection date for primary outcome measure)
c-reactive protein [ Time Frame: baseline, every 1-2 weeks during intervention , then end-of-study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00588978 on ClinicalTrials.gov Archive Site
HOMA (measure of insulin resistance) and sex steroids [ Time Frame: baseline, every 1-2 weeks during intervention, then end-of-study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Diet and/or Exercise-Induced Weight Loss on Cardiovascular Risk Factors
Longitudinal Impact of Diet and/or Exercise-Induced Weight Loss on Metabolic Markers of Cardiovascular Disease

The purpose of this pilot study is to examine the effect of diet and/or exercise-induced weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin levels and sex steroids in obese postmenopausal women.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiovascular Diseases
Behavioral: diet and/or exercise
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
  • Active Comparator: 1
    Diet alone
    Intervention: Behavioral: diet and/or exercise
  • Active Comparator: 2
    Exercise alone
    Intervention: Behavioral: diet and/or exercise
  • Active Comparator: 3
    Diet and exercise (combined)
    Intervention: Behavioral: diet and/or exercise
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
30
December 2008
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • obese postmenopausal women
  • able to exercise
  • non-smokers

Exclusion Criteria:

  • cardiovascular disease
  • medications that would interfere with outcome measures (e.g., including ACE inhibitors, lipid lowering medications, beta-blockers, etc)
  • known diabetes
Female
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588978
25094
No
Barbara I Gulanski, MD, MPH, Yale University School of Medicine
Yale University
Not Provided
Principal Investigator: Barbara I Gulanski, MD, MPH Yale Univeristy School of Medicine
Yale University
December 2007

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