Understanding the Roles of Hormones in Adipocyte Remodeling Following Menopause



Status:Not yet recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 50
Updated:3/9/2019
Start Date:April 1, 2019
End Date:March 31, 2021
Contact:Kara L Marlatt, PhD, MPH
Email:kara.marlatt@pbrc.edu
Phone:225-763-2871

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Understanding the Roles of Estradiol and Follicle-stimulating Hormone in Adipocyte Remodeling Following Surgical and Pharmacology-induced Menopause (RESUME-2 Study)

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).

This is a cross-sectional study where two groups of premenopausal women (ages 18-50 y) will
be enrolled in a parallel arm study:

- Arm 1 (Surgical Menopause): up to 6 women undergoing laparoscopic, elective bilateral
oophorectomy [Site: Pennington Biomedical Research Center].

- Arm 2 (Pharmacology-Induced Menopause): up to 6 women undergoing gonadal suppression via
leuprolide acetate (Lupron [AbbVie Inc.]) [Site: UC-Denver].

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.

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

- 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).

- Inconsistent use of medications listed above will be evaluated and left up to the
discretion of the Medical Investigator to evaluate safety.
We found this trial at
1
site
6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Phone: 225-763-2871
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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mi
from
Baton Rouge, LA
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