Status:
WITHDRAWN
Understanding the Roles of Hormones in Adipocyte Remodeling Following Menopause
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
University of Colorado, Denver
University of Alabama at Birmingham
Conditions:
Menopause Surgical
Estrogen Deficiency
Eligibility:
FEMALE
18-50 years
Brief Summary
The overarching aims of this study are to: 1. Characterize the rate of in vivo adipogenesis, and changes in adipose tissue gene and protein expression, in the scABD and scFEM depots of women undergoi...
Detailed Description
This is a cross-sectional study where two groups of premenopausal women (ages 18-50 y) will be enrolled in a parallel arm study: * Arm 1 (Surgical Menopause): up to 6 women undergoing laparoscopic, e...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy female
- Ages 18-50 y
- Planning to have either a laparoscopic bilateral oophorectomy or a laparoscopic unilateral oophorectomy (which would result in no remaining ovaries)
- Are willing to drink heavy water (2H2O) over an 8-week period
- Medically cleared for participation in the study by OB/GYN and Medical Investigator
- Are willing to have blood and fat tissue stored for future use
- EXCLUSION CRITERIA:
- Meet either of the following criteria:
- Have all 3 of the major menopause-related symptoms \[hot flashes, mood swings, insomnia (trouble sleeping)\]
- Have 2 of the major menopause-related symptom combinations \[hot flashes and mood swings, or hot flashes and insomnia (trouble sleeping)\]
- Unstable weight in the last 3 months \[gain or loss \>7 lb (or 3.2 kg)\]
- History of clinically diagnosed diabetes or a fasting blood glucose \>126 mg/dL
- Chronic use of systemic glucocorticoids, antipsychotic/antidepressant medications, thiazolidinediones and other medications that cause clinically significant weight gain, weight loss or are known to make changes in fat cell number/size \*
- Previous bariatric surgery (or other surgeries) for obesity or weight loss (\< 3 years ago)
- Use of over the counter or prescription weight loss products
- History of metabolic diseases (other than diabetes)
- History of neurological disease
- History of cardiovascular disease (or other chronic diseases)
- Pregnant, planning to become pregnant, or breastfeeding
- Use of hormone replacement therapy
- Unwilling to discontinue any form or hormonal therapy (e.g., contraceptives including birth control pills, vaginal ring, injections, implant, or skin patch; hormonal supplements, etc.) upon enrollment (after the Screening Visit).
- Inconsistent use of medications listed above will be evaluated and left up to the discretion of the Medical Investigator to evaluate safety.
Exclusion
Key Trial Info
Start Date :
April 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 11 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03856268
Start Date
April 1 2019
End Date
November 11 2022
Last Update
November 16 2022
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808