The Role of Estrogen in Adipocyte Remodeling Following Surgical Menopause

NCT ID: NCT03631680

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-25
• Study Completion Date: 2022-11-11

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

'Bilateral Oophorectomy Surgery' Group

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

Bilateral Oophorectomy Surgery

Intervention Type: PROCEDURE

Women undergoing elective, laparoscopic bilateral oophorectomy surgery will be enrolled.

'Comparative (Control)' Group

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

No interventions assigned to this group

Interventions

Bilateral Oophorectomy Surgery

Women undergoing elective, laparoscopic bilateral oophorectomy surgery will be enrolled.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Louisiana Clinical and Translational Science Center

OTHER

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Kara Marlatt

Postdoctoral Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kara L Marlatt, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

PBRC 2018-022

Identifier Type: -

Identifier Source: org_study_id