NCT03856268

Understanding the Roles of Hormones in Adipocyte Remodeling Following Menopause

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Menopause Surgical
• Estrogen Deficiency
• Adiposity
• Follicle-Stimulating Hormone Deficiency
• Hormone Deficiency

Interventions

Type	Name	Description
PROCEDURE	'Surgical Menopause' Group	Women undergoing laparoscopic oophorectomy surgery ('surgical menopause') will be enrolled at Pennington Biomedical.
DRUG	'Drug-Induced Menopause' Group	Women undergoing gonadal suppression via leuprolide acetate (Lupron \[AbbVie Inc.\]) will be enrolled at the University of Colorado-Denver.

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-11-11
• Completion: 2022-11-11
• First posted: 2019-02-27
• Last updated: 2022-11-16

Locations

1 site across 1 country: United States