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

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00588978

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

MedlinePlus related topics: Diets Exercise and Physical Fitness Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Longitudinal Impact of Diet and/or Exercise-Induced Weight Loss on Metabolic Markers of Cardiovascular Disease

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
1: Active Comparator Diet alone	Behavioral: diet and/or exercise Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
2: Active Comparator Exercise alone	Behavioral: diet and/or exercise Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
3: Active Comparator 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:	Yale University School of Medicine ( Barbara I Gulanski, MD, MPH )
Study ID Numbers:	25094
Study First Received:	December 27, 2007
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00588978 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

c-reactive protein
obesity
women's cardiovascular health

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss
Body Weight Changes

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Weight Loss
Body Weight Changes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009