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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: diet and/or exercise

• Registration Number: NCT00588978
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08-01
• Primary Completion: 2007-02-01
• Study First Submitted: 2007-12-27
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-09
• Study Completion: 2008-12-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	diet and/or exercise	Diet alone
3	diet and/or exercise	Diet and exercise (combined)
2	diet and/or exercise	Exercise alone

Primary Outcome Measures

Name	Time	Method
c-reactive protein	baseline, every 1-2 weeks during intervention , then end-of-study

Secondary Outcome Measures

Name	Time	Method
HOMA (measure of insulin resistance) and sex steroids	baseline, every 1-2 weeks during intervention, then end-of-study

Trial Locations

Locations (1)

Yale Center for Clinical Investigation; 🇺🇸 New Haven, Connecticut, United States