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

Yale University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Cardiovascular Diseases

Interventions

diet and/or exerciseBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Yale Center for Clinical Investigation

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

c-reactive protein

Time frame: baseline, every 1-2 weeks during intervention , then end-of-study

Secondary Outcomes

HOMA (measure of insulin resistance) and sex steroids

Time frame: baseline, every 1-2 weeks during intervention, then end-of-study

Data from ClinicalTrials.gov

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