Overview

This trial is active, not recruiting.

Condition cardiovascular diseases
Treatment diet and/or exercise
Sponsor Yale University
Start date August 2003
End date February 2007
Trial size 30 participants
Trial identifier NCT00588978, 25094

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Diet alone
diet and/or exercise
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
(Active Comparator)
Exercise alone
diet and/or exercise
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
(Active Comparator)
Diet and exercise (combined)
diet and/or exercise
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise

Primary Outcomes

Measure
c-reactive protein
time frame: baseline, every 1-2 weeks during intervention , then end-of-study

Secondary Outcomes

Measure
HOMA (measure of insulin resistance) and sex steroids
time frame: baseline, every 1-2 weeks during intervention, then end-of-study

Eligibility Criteria

Female participants from 40 years up to 65 years old.

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

Additional Information

Official title Longitudinal Impact of Diet and/or Exercise-Induced Weight Loss on Metabolic Markers of Cardiovascular Disease
Principal investigator Barbara I Gulanski, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by Yale University.