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NCT03631680 · ClinicalTrials.gov registry record
The Role of Estrogen in Adipocyte Remodeling Following Surgical Menopause
A clinical trial, sponsored by Pennington Biomedical Research Center.
- Terminated
- Registry status
- 2
- Enrollment target
NCT03631680: Clinical Trial study, sponsored by Pennington Biomedical Research Center.
NCT03631680 is a clinical trial that was terminated before completion, run by Pennington Biomedical Research Center. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03631680 was terminated before completion, sponsored by Pennington Biomedical Research Center.
- TERMINATED
- Registry status
- 2 participants
- Enrollment target
Study Summary
The overarching aim of this study is to assess the downstream effects of abrupt estrogen deficiency in women undergoing elective bilateral oophorectomy by studying: 1. the rate of in vivo adipogenesis in the subcutaneous abdominal (scABD) and subcutaneous femoral (scFEM) adipose tissue depots following bilateral oophorectomy surgery using an innovative (and tested) 8-week incorporation of stable isotope (deuterium; 2H) administered in the form of heavy water (2H2O) to endogenously label adipose tissue DNA; 2. the changes in expression of subcutaneous adipose tissue genes and proteins specific to adipocyte expansion and function; extracellular matrix remodeling and fibrosis; and inflammation in the scABD and scFEM depots before and after elective bilateral oophorectomy.
Primary Outcome
Deuterium from the deuterium-labeled water is incorporated into the newly-synthesized DNA of newly-formed fat cell precursor cells through cell replication. The latter carry over the label when they become fat cells through differentiation. Enzymatic digestion of the fat tissue isolates the individual cells constituting the fat tissue. Centrifugation of the cell suspension allows the separation of fat cells into a floating layer and a pellet comprised of stromal-vascular cells including the fat
Interventions
- PROCEDURE Bilateral Oophorectomy Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-09-25 |
| Est. Completion | 2022-11-11 |
Why NCT03631680 stopped before completion
NCT03631680 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Bilateral Oophorectomy Surgery is the first listed.
NCT03631680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03631680 about?
NCT03631680 is a clinical study titled "The Role of Estrogen in Adipocyte Remodeling Following Surgical Menopause". The overarching aim of this study is to assess the downstream effects of abrupt estrogen deficiency in women undergoing elective bilateral oophorectomy by studying: 1. the rate of in vivo adipogenesis in the subcutaneous abdominal (scABD) and subcutaneous femoral (scFEM) adipose tissue depots follo...
What is the current status of trial NCT03631680?
This trial is currently terminated. The enrollment target is 2 participants. The study started on 2018-09-25. Estimated completion is 2022-11-11.
What interventions are being tested in trial NCT03631680?
The interventions under investigation include: Bilateral Oophorectomy Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03631680?
This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.
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