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

NCT ID: NCT00588978

Last Updated: 2020-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-01

Study Completion Date

2008-12-01

Brief Summary

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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

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Diet alone

Group Type ACTIVE_COMPARATOR

diet and/or exercise

Intervention Type BEHAVIORAL

Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise

2

Exercise alone

Group Type ACTIVE_COMPARATOR

diet and/or exercise

Intervention Type BEHAVIORAL

Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise

3

Diet and exercise (combined)

Group Type ACTIVE_COMPARATOR

diet and/or exercise

Intervention Type BEHAVIORAL

Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise

Interventions

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diet and/or exercise

Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Yale University School of Medicine

Principal Investigators

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Barbara I Gulanski, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale Univeristy School of Medicine

Locations

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Yale Center for Clinical Investigation

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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25094

Identifier Type: -

Identifier Source: org_study_id

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