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

  • STATUS
    Recruiting
  • days left to enroll
    60
  • participants needed
    12
  • sponsor
    Pennington Biomedical Research Center
Updated on 11 October 2022
fats
Accepts healthy volunteers

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).

Description

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.

Details
Condition Menopause Surgical, Estrogen Deficiency, Adiposity, Follicle-Stimulating Hormone Deficiency, Hormone Deficiency
Treatment 'Surgical Menopause' Group, 'Drug-Induced Menopause' Group
Clinical Study IdentifierNCT03856268
SponsorPennington Biomedical Research Center
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

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
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