Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
---|---|
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00023543 |
The purpose of this study is to test the effect of lifestyle intervention on subclinical cardiovascular disease measures in women taking hormone replacement therapy (HRT).
Condition | Intervention | Phase |
---|---|---|
Cardiovascular Diseases Atherosclerosis Postmenopause Heart Diseases |
Behavioral: Diet, fat-restricted Behavioral: Exercise |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Single Group Assignment |
Official Title: | Reduction of Triglycerides in Women on HRT |
Estimated Enrollment: | 500 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Participants will reduce total fat intake to 17 percent of calories, 1300 kilo calories, and increase moderate activity to 150-240 minutes per week to obtain a 10 percent reduction in weight.
|
Behavioral: Diet, fat-restricted
Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods.
Behavioral: Exercise
Rigorous, stepped care approach to reach 150 min/week of physical activity.
|
BACKGROUND:
Cardiovascular disease is a common cause of morbidity and mortality in older women. Better methods of prevention via health promotion are needed. Estrogen HRT may beneficially affect women's cardiovascular health, based on evidence from observational studies, but recent trial evidence suggests HRT may actually lead to increased risk of cardiovascular disease in new users. Understanding this untoward effect of HRT and how to prevent it is a significant aim.
DESIGN NARRATIVE:
This randomized trial of 500 women on HRT for at least two years, aged 52-60 years, and three or more years postmenopausal will test whether reduction in waist circumference, triglycerides, dense low density lipoprotein cholesterol (LDLc), number of LDL particles, C-reactive protein, and plasminogen activator inhibitor-I (PAI-I) by aggressive diet and exercise, versus a health education control, and will decrease progression or result in regression of measures of subclinical vascular disease. The intervention is designed to reduce total fat intake to 17 percent of calories, 1300 kilo calories, and increase moderate activity to 150-240 minutes per week to obtain a 10 percent reduction in weight. The primary endpoint will be a 20 percent or at least a 20 mg decrease in triglyceride levels, a 5 cm decrease in waist circumference, and a 10 percent decrease in LDLc. This will result in changes in subclinical measurements, including carotid ultrasound, electron beam computer tomography of the coronary artery and aorta, pulse wave velocity, endothelial function, and tonometry of the radial artery. Nuclear magnetic resonance spectroscopy of lipoproteins, inflammatory markers, and estrogen metabolites will also be evaluated.
Ages Eligible for Study: | 52 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of Pittsburgh ( Lewis H. Kuller, MD, DrPH/University Professor of Public Health ) |
Study ID Numbers: | 981, R01 HL66468 |
Study First Received: | September 7, 2001 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00023543 History of Changes |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Atherosclerosis Heart Diseases |
Vascular Diseases Arteriosclerosis Hormones |
Arterial Occlusive Diseases Atherosclerosis Heart Diseases |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis |