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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
History of Changes
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
 Behavioral: diet and/or exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Longitudinal Impact of Diet and/or Exercise-Induced Weight Loss on Metabolic Markers of Cardiovascular Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • c-reactive protein [ Time Frame: baseline, every 1-2 weeks during intervention , then end-of-study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: August 2003
Estimated Study Completion Date: December 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Diet alone
 Behavioral: diet and/or exercise
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
Active Comparator: 2
Exercise alone
 Behavioral: diet and/or exercise
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
Active Comparator: 3
Diet and exercise (combined)
 Behavioral: diet and/or exercise
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588978

Locations
United States, Connecticut
Yale Center for Clinical Investigation
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Barbara I Gulanski, MD, MPH Yale Univeristy School of Medicine
  More Information

No publications provided

Responsible Party: Barbara I Gulanski, MD, MPH, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00588978     History of Changes
Other Study ID Numbers: 25094
Study First Received: December 27, 2007
Last Updated: January 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
c-reactive protein
obesity
women's cardiovascular health

Additional relevant MeSH terms:
Cardiovascular Diseases
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 17, 2012