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PI left the institution and the study was closed.
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| Name | Class |
|---|---|
| Louisiana Clinical and Translational Science Center | OTHER |
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The overarching aim of this study is to assess the downstream effects of abrupt estrogen deficiency in women undergoing elective bilateral oophorectomy by studying:
This is a cross-sectional study that will enroll up to 10 women undergoing laparoscopic, elective bilateral oophorectomy at a local hospital in Baton Rouge, LA. Women will complete 7 study visits over 3 months; a single screening visit to assess eligibility, a pre-bilateral oophorectomy visit for imaging and adipose tissue biopsy collection, and 5 post-bilateral oophorectomy visits to "dose", maintain compliance and subject retention, and perform follow-up imaging and adipose tissue biopsy collection for outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 'Bilateral Oophorectomy Surgery' Group | Premenopausal women planning to undergo a laparoscopic, elective bilateral oophorectomy surgery. |
| |
| 'Comparative (Control)' Group | Premenopausal women with normal menstrual cycles from a previously completed study at Pennington Biomedical Research Center [NCT01748994] will serve as a comparator (control) group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Oophorectomy Surgery | Procedure | Women undergoing elective, laparoscopic bilateral oophorectomy surgery will be enrolled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of in vivo adipogenesis (via deuterium-enrichment of adipose tissue DNA) | 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 cell precursor cells and small fat cells. As the fat cell precursor cells and small adipocytes have the property to attach quickly to plastic surfaces of culture dishes, a brief culturing of the stromal-vascular cells sorts these cells from the remaining cells. Thus, measuring the deuterium-enrichment of DNA from plastic-adherent stromal-vascular cells indicates the rate of in vivo formation of new mature fat cells and pre-adipocytes, a process collectively termed adipogenesis. | Change from baseline in enrichment of DNA of adipose cells with deuterium at 8 weeks post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Size of adipocytes | Fat cell size will be determined using osmium fixation of the lipids and measurement of their diameter with Coulter Counter followed by calculation of fat cell volume. The mean lipid content of fat cells will be calculated by multiplying the fat cell volume by the density of triolein (0.915). | Change from baseline in size of adipocytes at 8 weeks post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
Premenopausal women planning to undergo elective, laparoscopic bilateral oophorectomy surgery.
Healthy women that are planning to undergo elective, laparoscopic bilateral oophorectomy surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Kara L Marlatt, PhD, MPH | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Adipose tissue
| Number of adipocytes | Fat cell number will be estimated by dividing the volume of adipose tissue depot of interest to the mean fat cell volume or the fat mass of the depot to the mean lipid content in fat cell. | Change from baseline in number of adipocytes at 8 weeks post-surgery |
| Body composition (by Dual-energy X-ray Absorptiometry (DXA)) | Fat mass, fat-free mass, and percent body fat will be assessed using a whole-body scanner GE iDXA. | Change from baseline in body composition at 8 weeks post-surgery |
| Body composition (by Magnetic Resonance Imaging (MRI)) | Visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and total adipose tissue (TAT) will be assessed by MRI scan (3T GE Discovery 750w). | Change from baseline in body composition at 8 weeks post-surgery |
| Adipose tissue gene and protein expression | Expression levels of genes and proteins involved in adipocyte expansion and function (ERα, PPARγ2, C/EBPα, aromatase, adiponectin, and LPL), extracellular matrix remodeling and fibrosis (COL6(a1, a2, a3), COL4a1, and TGFβ), and inflammation (IL-6 and TNFα) will be assessed. | Changes from baseline in gene and protein expression at 8 weeks post-surgery |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |