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

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ClinicalTrials.gov Identifier: NCT00588978
Recruitment Status : Unknown
Verified December 2007 by Yale University.
Recruitment status was:  Active, not recruiting
First Posted : January 9, 2008
Last Update Posted : January 9, 2008
Sponsor:
Information provided by:
Yale University

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: diet and/or exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Longitudinal Impact of Diet and/or Exercise-Induced Weight Loss on Metabolic Markers of Cardiovascular Disease
Study Start Date : August 2003
Actual Primary Completion Date : February 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. c-reactive protein [ Time Frame: baseline, every 1-2 weeks during intervention , then end-of-study ]

Secondary Outcome Measures :
  1. HOMA (measure of insulin resistance) and sex steroids [ Time Frame: baseline, every 1-2 weeks during intervention, then end-of-study ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Barbara I Gulanski, MD, MPH, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00588978     History of Changes
Other Study ID Numbers: 25094
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: January 9, 2008
Last Verified: December 2007

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