Back to resultsImpact of Diet and/or Exercise-induced Weight Loss on Cardiovascular Risk Factors
Primary Purpose
Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diet and/or exercise
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases focused on measuring c-reactive protein, obesity, women's cardiovascular health
Eligibility 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
Sites / Locations
- Yale Center for Clinical Investigation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Diet alone
Exercise alone
Diet and exercise (combined)
Outcomes
Primary Outcome Measures
c-reactive protein
Secondary Outcome Measures
HOMA (measure of insulin resistance) and sex steroids
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00588978
Brief Title
Impact of Diet and/or Exercise-induced Weight Loss on Cardiovascular Risk Factors
Official Title
Longitudinal Impact of Diet and/or Exercise-induced Weight Loss on Metabolic Markers of Cardiovascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2003 (Actual)
Primary Completion Date
February 1, 2007 (Actual)
Study Completion Date
December 1, 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
c-reactive protein, obesity, women's cardiovascular health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Diet alone
Arm Title
2
Arm Type
Active Comparator
Arm Description
Exercise alone
Arm Title
3
Arm Type
Active Comparator
Arm Description
Diet and exercise (combined)
Intervention Type
Behavioral
Intervention Name(s)
diet and/or exercise
Intervention Description
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
Primary Outcome Measure Information:
Title
c-reactive protein
Time Frame
baseline, every 1-2 weeks during intervention , then end-of-study
Secondary Outcome Measure Information:
Title
HOMA (measure of insulin resistance) and sex steroids
Time Frame
baseline, every 1-2 weeks during intervention, then end-of-study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara I Gulanski, MD, MPH
Organizational Affiliation
Yale Univeristy School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Center for Clinical Investigation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Diet and/or Exercise-induced Weight Loss on Cardiovascular Risk Factors
We'll reach out to this number within 24 hrs