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

Cardiovascular Diseases Clinical Trial

Official title:

Longitudinal Impact of Diet and/or Exercise-induced Weight Loss on Metabolic Markers of Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588978
• Other study ID #: 25094
• Status: Completed
• Phase: N/A
• Start date: August 1, 2003
• Est. completion date: December 1, 2008

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2008
• Est. primary completion date: February 1, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Weight Loss

Intervention

Behavioral:
• diet and/or exercise
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigation	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	c-reactive protein		baseline, every 1-2 weeks during intervention , then end-of-study
Secondary	HOMA (measure of insulin resistance) and sex steroids		baseline, every 1-2 weeks during intervention, then end-of-study