Reduction of Triglycerides in Women on Hormone Replacement Therapy
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|ClinicalTrials.gov Identifier: NCT00023543|
Recruitment Status : Completed
First Posted : September 7, 2001
Last Update Posted : June 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Atherosclerosis Postmenopause Heart Diseases||Behavioral: Diet, fat-restricted Behavioral: Exercise||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||508 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduction of Triglycerides in Women on HRT|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
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.
- Measures of subclinical disease [ Time Frame: 5 years ]
- Change in coronary calcium (EBCT) [ Time Frame: 5 years ]
- Change in carotid intima media wall thickness [ Time Frame: 5 years ]
- Change in vascular stiffness (PWV) [ Time Frame: 5 years ]
- Change in waist circumference and weight [ Time Frame: 5 years ]
- Change in LDL particles, triglycerides and small, medium and large LDL particles [ Time Frame: 5 years ]
- Change in HDL particles [ Time Frame: 5 years ]
- Change in insulin and glucose [ Time Frame: 5 years ]
- Change in systolic blood pressure, diastolic blood pressure [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023543
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15261|
|Study Chair:||Lewis H. Kuller, MD, DPH||University of Pittsburgh|