Cardiovascular Diseases Clinical Trial
Official title:
Reduction of Triglycerides in Women on HRT
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).
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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