Understanding the Roles of Hormones in Adipocyte Remodeling Following Menopause (NCT03856268) | Clinical Trial Compass
WithdrawnNot Applicable
Understanding the Roles of Hormones in Adipocyte Remodeling Following Menopause
Stopped: PI left the institution.
United States0Started 2019-04-01
Plain-language 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 undergoing surgical menopause (↓E2, ↑FSH).
2. Characterize the rate of in vivo adipogenesis, and changes in adipose tissue gene and protein expression, in the scABD and scFEM depots of women undergoing gonadal suppression (↓E2, ↓FSH).
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
What they're measuring
1
Rate of in vivo adipogenesis (via deuterium-enrichment of adipose tissue DNA)
Timeframe: Change from baseline in enrichment of DNA of adipose cells with deuterium at 8 weeks