Cardiovascular Diseases Clinical Trial
Official title:
Reduction of Triglycerides in Women on HRT
Verified date | June 2013 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 508 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 52 Years to 60 Years |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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 Act — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measures of subclinical disease | 5 years | No | |
Primary | Change in coronary calcium (EBCT) | 5 years | No | |
Primary | Change in carotid intima media wall thickness | 5 years | No | |
Primary | Change in vascular stiffness (PWV) | 5 years | No | |
Secondary | Change in waist circumference and weight | 5 years | No | |
Secondary | Change in LDL particles, triglycerides and small, medium and large LDL particles | 5 years | No | |
Secondary | Change in HDL particles | 5 years | No | |
Secondary | Change in insulin and glucose | 5 years | No | |
Secondary | Change in systolic blood pressure, diastolic blood pressure | 5 years | No |
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