NCT00023543

Reduction of Triglycerides in Women on Hormone Replacement Therapy

Reduction of Triglycerides in Women on HRT

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 508 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 52 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Cardiovascular Diseases
• Atherosclerosis
• Postmenopause
• Heart Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2001-09-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2001-09-07
• Last updated: 2013-06-19

Locations

1 site across 1 country: United States