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PI left the institution.
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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| University of Alabama at Birmingham | OTHER |
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The overarching aims of this study are to:
This is a cross-sectional study where two groups of premenopausal women (ages 18-50 y) will be enrolled in a parallel arm study:
We will compare each arm of women to non-oophorectomized, premenopausal women (controls) with normal menstrual cycles (Apple&Pear study; NCT01748994; PI: Ravussin) selectively matched (1:2) for age and BMI. The Apple&Pear study uses the same in vivo adipogenesis labeling protocol, with similar age and BMI criteria, as the proposed study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1: 'Surgical Menopause' Group | Premenopausal women having an oophorectomy. |
| |
| ARM 2: "Drug-Induced Menopause' | Premenopausal women with gonadal suppression |
| |
| 'Comparative (Control)' Group | Premenopausal women with regular cycles. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 'Surgical Menopause' Group | Procedure | Women undergoing laparoscopic oophorectomy surgery ('surgical menopause') will be enrolled at Pennington Biomedical. |
|
| 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 |
| 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:
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).
Premenopausal women planning to undergo elective, laparoscopic bilateral oophorectomy surgery OR gonadal suppression via leuprolide acetate (Lupron [AbbVie Inc.]).
Women (aged 18-50 y) will be enrolled. Women will be pre-menopausal, not pregnant, and not using hormone therapy or have medical indication for increased cancer risk.
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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 |
Data will be made available upon request.
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Adipose tissue
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| 'Drug-Induced Menopause' Group | Drug | Women undergoing gonadal suppression via leuprolide acetate (Lupron [AbbVie Inc.]) will be enrolled at the University of Colorado-Denver. |
|
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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