Reduction of Triglycerides in Women on Hormone Replacement Therapy

University of Pittsburgh

Status and phase: Completed; Phase 2

Conditions: Cardiovascular Diseases; Heart Diseases; Postmenopause; Atherosclerosis

Treatments: Behavioral: Diet, fat-restricted; Behavioral: Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00023543

R01HL066468 (U.S. NIH Grant/Contract)

R01HL066468-06 (U.S. NIH Grant/Contract)

981

Details and patient eligibility

About

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).

Full 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.

Enrollment: 508 patients

Sex: Female

Ages: 52 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• On HRT for at least two years
• Women 52 to 60 years of age
• Three or more years postmenopausal
• Waist circumference greater than 80 cm
• LDLc between 100 and 160 mg/dl
• Body mass index 25-39.9 kg/m2
• Blood Pressure less than 160/95 mm Hg
• Beck Depression Inventory Score less than 20

Exclusion criteria

• Current use of cholesterol-lowering medication
• Diagnosis of diabetes
• On diabetes medication

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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508 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise

Behavioral: Diet, fat-restricted