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).
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.
Status: Active, not recruiting (Phase 2). Started on September 1st, 2001. Ended on June 1st, 2009.
Enrollment: 500 subjects
Study Type: Interventional
Study Design:
- Prevention
- Randomized
- Open Label
- Single Group Assignment
Conditions:
Interventions:
- Behavioral: Diet, fat-restricted
- Behavioral: Exercise
Eligibility
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
- Gender
Female
- Mininum Age
52 Years
- Maximum Age
60 Years
- Healthy Volunteers
No
Resources
Source: National Heart, Lung, and Blood Institute (NHLBI)
Authority: United States: Federal Government
Locations
-
University of Pittsburgh
Pittsburgh
Pennsylvania
15261
United States
Officials
Lewis H. Kuller, MD, DPH (Study Chair, University of Pittsburgh)
Sponsors
National Heart, Lung, and Blood Institute (NHLBI) (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- October 1st, 2008
- First Received
- October 8th, 2008
- Last Changed
- October 8th, 2008
Information obtained from ClinicalTrials.gov on October 09, 2008. Link to the current ClinicalTrials.gov record.
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