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

April 16, 2020 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Center for Clinical Investigation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Diet alone
Behavioral: diet and/or exercise
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
ACTIVE_COMPARATOR: 2
Exercise alone
Behavioral: diet and/or exercise
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
ACTIVE_COMPARATOR: 3
Diet and exercise (combined)
Behavioral: diet and/or exercise
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
c-reactive protein
Time Frame: baseline, every 1-2 weeks during intervention , then end-of-study
baseline, every 1-2 weeks during intervention , then end-of-study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Barbara I Gulanski, MD, MPH, Yale Univeristy School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2003

Primary Completion (ACTUAL)

February 1, 2007

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

December 27, 2007

First Submitted That Met QC Criteria

January 8, 2008

First Posted (ESTIMATE)

January 9, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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