Status:
COMPLETED
AFTER: Altering Fat Through Estrogen and Raloxifene
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Postmenopause
Eligibility:
FEMALE
50-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether estrogens specifically promote a reduction in fat from abdominal regions during weight loss and/or prevent the accumulation of abdominal fat during we...
Detailed Description
The general aim of this study is to determine whether estrogen-based hormone therapy (HT) in postmenopausal women reduces the accumulation of abdominal visceral fat and whether this is a contributing ...
Eligibility Criteria
Inclusion
- postmenopausal women
- aged 50-70 yr
- healthy, as determined by medical history, physical examination, blood chemistries, and a graded exercise stress test with monitoring of blood pressure and ECG
- good cognitive function.
Exclusion
- contraindications to estrogen or raloxifene treatment, including history of or active breast cancer or other estrogen-dependent neoplasms, acute liver disease, undiagnosed vaginal bleeding, and active or history of blood clotting disorders
- mild or more severe cognitive impairment, indicated by a MMSE score \<26
- clinically significant abnormal resting electrocardiogram (ECG), angina and/or ECG evidence of acute myocardial ischemia during a maximal exercise stress test
- resting blood pressure above 150 mmHg systolic or 90 mmHg diastolic
- left bundle branch blocks, A-V block greater than first degree, clinically significant arrhythmias
- congestive heart failure
- pulmonary emboli in the previous 6 months
- aortic stenosis
- chronic infections
- orthopedic or other problems that would interfere with participation in the exercise program
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00149604
Start Date
March 1 2000
End Date
February 1 2006
Last Update
December 2 2009
Active Locations (1)
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1
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, United States, 80262