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 range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
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
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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