The Role of Estrogen in Adipocyte Remodeling Following Surgical Menopause

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    10
  • sponsor
    Pennington Biomedical Research Center
Updated on 24 January 2021
cancer
fats

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.

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.

Details
Condition adiposity, Obesity, Estrogen Deficiency, Menopause Surgical, surgical menopause
Treatment Bilateral Oophorectomy Surgery
Clinical Study IdentifierNCT03631680
SponsorPennington Biomedical Research Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 45 yrs?
Are you female?
Do you have any of these conditions: Estrogen Deficiency or Obesity or Menopause Surgical or adiposity?
Do you have any of these conditions: Estrogen Deficiency or adiposity or surgical menopause or Obesity or Menopause Surgical?
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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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