Status:
COMPLETED
Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Menopause
Eligibility:
FEMALE
47-52 years
Brief Summary
The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.
Detailed Description
The effect of menopause on body composition and cardiovascular risk in healthy caucasian women has been the subject of much study. In contrast, there are few data available on menopause in African-Ame...
Eligibility Criteria
Inclusion
- Age 47-52 yr, at time of enrollment
- Body Mass Index 25-40
- Normal oral glucose tolerance test by National Diabetes Data Group criteria
- Premenopausal, defined by FSH levels \<30mIU/ml and at least 5 menstrual periods in the last 6 months
- Able to confirm ethnic heritage of past 2 generations in family
Exclusion
- hypertension or hypercholesterolemia requiring medication
- regular use of medications that influence glucose tolerance
- use of oral contraceptives within the past 6 months
- history of myocardial infarction or significant coronary vascular disease or stroke
- history of endocrine, kidney, or liver disease or malignancy
- any psychopathology, including eating disorders, substance abuse, and major depression
- unable to complete longitudinal study commitment, including anticipating moving out of the area within the next 5 years.
Key Trial Info
Start Date :
February 1 1998
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00412269
Start Date
February 1 1998
End Date
March 1 2007
Last Update
January 25 2016
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808