The Role of Estrogen in Adipocyte Remodeling Following Surgical Menopause (RESUME)

Pennington Biomedical Research Center

Status: Terminated

Conditions: Menopause Surgical; Estrogen Deficiency; Adiposity

Treatments: Procedure: Bilateral Oophorectomy Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03631680

PBRC 2018-022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy females
• Ages 18-45 y
• BMI between 25 kg/m2 and 40 kg/m2 (±0.5 kg/m2 will be accepted)
• Are pre-menopausal (follicle-stimulating hormone, FSH<40 mIU/mL)
• Asymptomatic for the following menopause-related symptoms: hot flashes, insomnia (trouble sleeping), or mood swings
• Planning to have a laparoscopically, elective bilateral oophorectomy
• No medical indication for increased cancer risk
• 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

• Unstable weight in the last 3 months [gain or loss >7 lb (or 3.2 kg)]
• Significant changes in diet or physical activity level within the past month
• Smoking or use of tobacco products within the last 3 months
• Amenorrhea (or absence of regular monthly cycles)
• History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
• Average screening blood pressure >140/90 mmHg
• Chronic use of systemic glucocorticoids, systemic adrenergic-stimulating agents, 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
• 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)
• Unable or unwilling to have an MRI performed
• 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).

Trial design

2 participants in 2 patient groups

'Bilateral Oophorectomy Surgery' Group

Description:

Premenopausal women planning to undergo a laparoscopic, elective bilateral oophorectomy surgery.

Treatment:

Procedure: Bilateral Oophorectomy Surgery

'Comparative (Control)' Group

Description:

Premenopausal women with normal menstrual cycles from a previously completed study at Pennington Biomedical Research Center \[NCT01748994\] will serve as a comparator (control) group.