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

Yale University

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Behavioral: diet and/or exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00588978

25094

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

1

Active Comparator group

Description:

Diet alone

Treatment:

Behavioral: diet and/or exercise

2

Active Comparator group

Description:

Exercise alone

Treatment:

Behavioral: diet and/or exercise

3

Active Comparator group

Description:

Diet and exercise (combined)

Treatment:

Behavioral: diet and/or exercise