NCT03631680

The Role of Estrogen in Adipocyte Remodeling Following Surgical Menopause

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The overarching aim of this study is to assess the downstream effects of abrupt estrogen deficiency in women undergoing elective bilateral oophorectomy by studying: 1. the rate of in vivo adipogenesis in the subcutaneous abdominal (scABD) and subcutaneous femoral (scFEM) adipose tissue depots following bilateral oophorectomy surgery using an innovative (and tested) 8-week incorporation of stable isotope (deuterium; 2H) administered in the form of heavy water (2H2O) to endogenously label adipose tissue DNA; 2. the changes in expression of subcutaneous adipose tissue genes and proteins specific to adipocyte expansion and function; extracellular matrix remodeling and fibrosis; and inflammation in the scABD and scFEM depots before and after elective bilateral oophorectomy.

Detailed description

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.

Conditions

• Menopause Surgical
• Estrogen Deficiency
• Adiposity

Interventions

Type	Name	Description
PROCEDURE	Bilateral Oophorectomy Surgery	Women undergoing elective, laparoscopic bilateral oophorectomy surgery will be enrolled.

Timeline

• Start date: 2018-09-25
• Primary completion: 2022-11-11
• Completion: 2022-11-11
• First posted: 2018-08-15
• Last updated: 2022-11-16

Locations

1 site across 1 country: United States