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OpenTrials
Completed

NCT Number: NCT00588978

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

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.

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Key information

Conditions

Cardiovascular Diseases Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale Center for Clinical Investigation

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diet and/or exercise

Behavioral

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

Primary outcomes

  1. c-reactive protein

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

Secondary outcomes

  1. HOMA (measure of insulin resistance) and sex steroids

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Jan 9, 2008
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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