Menopause SurgicalRESUMENCT03631680
The Role of Estrogen in Adipocyte Remodeling Following Surgical Menopause
An observational study of Menopause Surgical and Estrogen Deficiency, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause Surgical, Estrogen Deficiency, Adiposity
- What is being tested?
- Bilateral Oophorectomy Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2018to 11 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women that are planning to undergo elective, laparoscopic bilateral oophorectomy surgery.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
The overarching aim of this study is to assess the downstream effects of abrupt estrogen deficiency in women undergoing elective bilateral oophorectomy by studying:
- 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;
- 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.
Read the 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
- Being tested
- Bilateral Oophorectomy Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Oophorectomy SurgeryProcedure or surgery
Women undergoing elective, laparoscopic bilateral oophorectomy surgery will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| 'Bilateral Oophorectomy Surgery' Group | Premenopausal women planning to undergo a laparoscopic, elective bilateral oophorectomy surgery. Receives: Procedure: Bilateral Oophorectomy Surgery | |
| '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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of in vivo adipogenesis (via deuterium-enrichment of adipose tissue DNA)
Deuterium from the deuterium-labeled water is incorporated into the newly-synthesized DNA of newly-formed fat cell precursor cells through cell replication. The latter carry over the label when they become fat cells through differentiation. Enzymatic digestion of the fat tissue isolates the individual cells constituting the fat tissue. Centrifugation of the cell suspension allows the separation of fat cells into a floating layer and a pellet comprised of stromal-vascular cells including the fat cell precursor cells and small fat cells. As the fat cell precursor cells and small adipocytes have the property to attach quickly to plastic surfaces of culture dishes, a brief culturing of the stromal-vascular cells sorts these cells from the remaining cells. Thus, measuring the deuterium-enrichment of DNA from plastic-adherent stromal-vascular cells indicates the rate of in vivo formation of new mature fat cells and pre-adipocytes, a process collectively termed adipogenesis.
Measured: Change from baseline in enrichment of DNA of adipose cells with deuterium at 8 weeks post-surgery
Secondary outcomes (5)
Size of adipocytes
Fat cell size will be determined using osmium fixation of the lipids and measurement of their diameter with Coulter Counter followed by calculation of fat cell volume. The mean lipid content of fat cells will be calculated by multiplying the fat cell volume by the density of triolein (0.915).
Measured: Change from baseline in size of adipocytes at 8 weeks post-surgery
Number of adipocytes
Fat cell number will be estimated by dividing the volume of adipose tissue depot of interest to the mean fat cell volume or the fat mass of the depot to the mean lipid content in fat cell.
Measured: Change from baseline in number of adipocytes at 8 weeks post-surgery
Body composition (by Dual-energy X-ray Absorptiometry (DXA))
Fat mass, fat-free mass, and percent body fat will be assessed using a whole-body scanner GE iDXA.
Measured: Change from baseline in body composition at 8 weeks post-surgery
Body composition (by Magnetic Resonance Imaging (MRI))
Visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and total adipose tissue (TAT) will be assessed by MRI scan (3T GE Discovery 750w).
Measured: Change from baseline in body composition at 8 weeks post-surgery
Adipose tissue gene and protein expression
Expression levels of genes and proteins involved in adipocyte expansion and function (ERα, PPARγ2, C/EBPα, aromatase, adiponectin, and LPL), extracellular matrix remodeling and fibrosis (COL6(a1, a2, a3), COL4a1, and TGFβ), and inflammation (IL-6 and TNFα) will be assessed.
Measured: Changes from baseline in gene and protein expression at 8 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start25 Sep 2018
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Why it stopped: PI left the institution and the study was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana Clinical and Translational Science Center
- Responsible party
- Principal investigator, Kara Marlatt, Pennington Biomedical Research Center
- Investigators
- Kara L Marlatt, PhD, MPH, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631680
- Sponsor's protocol ID
- PBRC 2018-022
- Acronym
- RESUME
- Status last verified
- Nov 2022
- First submitted
- 9 Aug 2018
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Estrogen in Adipocyte Remodeling Following Surgical Menopause
- ClinicalTrials.gov ID
- NCT03631680
- Acronym / sponsor ID
- RESUME / PBRC 2018-022
- Conditions
- Menopause Surgical, Estrogen Deficiency, Adiposity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left the institution and the study was closed.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Louisiana Clinical and Translational Science Center
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching aim of this study is to assess the downstream effects of abrupt estrogen deficiency in women undergoing elective bilateral oophorectomy by studying:
- 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;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'Bilateral Oophorectomy Surgery' Group | – | Procedure: Bilateral Oophorectomy SurgeryPremenopausal women planning to undergo a laparoscopic, elective bilateral oophorectomy surgery. |
| '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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women that are planning to undergo elective, laparoscopic bilateral oophorectomy surgery.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Oophorectomy SurgeryWomen undergoing elective, laparoscopic bilateral oophorectomy surgery will be enrolled. | Procedure or surgery | 'Bilateral Oophorectomy Surgery' Group |
Primary outcome
Rate of in vivo adipogenesis (via deuterium-enrichment of adipose tissue DNA)
Time frame: Change from baseline in enrichment of DNA of adipose cells with deuterium at 8 weeks post-surgery
Deuterium from the deuterium-labeled water is incorporated into the newly-synthesized DNA of newly-formed fat cell precursor cells through cell replication. The latter carry over the label when they become fat cells through differentiation. Enzymatic digestion of the fat tissue isolates the individual cells constituting the fat tissue. Centrifugation of the cell suspension allows the separation of fat cells into a floating layer and a pellet comprised of stromal-vascular cells including the fat cell precursor cells and small fat cells. As the fat cell precursor cells and small adipocytes have the property to attach quickly to plastic surfaces of culture dishes, a brief culturing of the stromal-vascular cells sorts these cells from the remaining cells. Thus, measuring the deuterium-enrichment of DNA from plastic-adherent stromal-vascular cells indicates the rate of in vivo formation of new mature fat cells and pre-adipocytes, a process collectively termed adipogenesis.
5 secondary outcomes
Size of adipocytes
Time frame: Change from baseline in size of adipocytes at 8 weeks post-surgery
Number of adipocytes
Time frame: Change from baseline in number of adipocytes at 8 weeks post-surgery
Body composition (by Dual-energy X-ray Absorptiometry (DXA))
Time frame: Change from baseline in body composition at 8 weeks post-surgery
Body composition (by Magnetic Resonance Imaging (MRI))
Time frame: Change from baseline in body composition at 8 weeks post-surgery
Adipose tissue gene and protein expression
Time frame: Changes from baseline in gene and protein expression at 8 weeks post-surgery
Results and safety
The study was stopped early (reason given: PI left the institution and the study was closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara L Marlatt, PhD, MPH principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause Surgical and Estrogen Deficiency, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left the institution and the study was closed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of in vivo adipogenesis (via deuterium-enrichment of adipose tissue DNA) (time frame: Change from baseline in enrichment of DNA of adipose cells with deuterium at 8 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.