Reduction of Triglycerides in Women on Hormone Replacement Therapy
NCT ID: NCT00023543
Last Updated: 2013-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
508 participants
INTERVENTIONAL
2001-09-30
2010-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
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.
Diet, fat-restricted
Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods.
Exercise
Rigorous, stepped care approach to reach 150 min/week of physical activity.
Interventions
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Diet, fat-restricted
Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods.
Exercise
Rigorous, stepped care approach to reach 150 min/week of physical activity.
Eligibility Criteria
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Inclusion Criteria
* 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
* Diagnosis of diabetes
* On diabetes medication
52 Years
60 Years
FEMALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Principal Investigators
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Lewis H. Kuller, MD, DPH
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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References
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Kuller LH, Kinzel LS, Pettee KK, Kriska AM, Simkin-Silverman LR, Conroy MB, Averbach F, Pappert WS, Johnson BD. Lifestyle intervention and coronary heart disease risk factor changes over 18 months in postmenopausal women: the Women On the Move through Activity and Nutrition (WOMAN study) clinical trial. J Womens Health (Larchmt). 2006 Oct;15(8):962-74. doi: 10.1089/jwh.2006.15.962.
Kuller LH, Pettee Gabriel KK, Kinzel LS, Underwood DA, Conroy MB, Chang Y, Mackey RH, Edmundowicz D, Tyrrell KS, Buhari AM, Kriska AM. The Women on the Move Through Activity and Nutrition (WOMAN) study: final 48-month results. Obesity (Silver Spring). 2012 Mar;20(3):636-43. doi: 10.1038/oby.2011.80. Epub 2011 Apr 14.
Gabriel KP, McClain JJ, Schmid KK, Storti KL, High RR, Underwood DA, Kuller LH, Kriska AM. Issues in accelerometer methodology: the role of epoch length on estimates of physical activity and relationships with health outcomes in overweight, post-menopausal women. Int J Behav Nutr Phys Act. 2010 Jun 15;7:53. doi: 10.1186/1479-5868-7-53.
Other Identifiers
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