Menopause SurgicalRESUME-2NCT03856268
Understanding the Roles of Hormones in Adipocyte Remodeling Following 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 aims of this study are to: 1. Characterize the rate of in vivo adipogenesis, and changes in adipose tissue gene and protein expression, in the scABD and scFEM depots of women undergoing surgical menopause (↓E2, ↑FSH). 2. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause Surgical, Estrogen Deficiency, Adiposity
- What is being tested?
- 'Surgical Menopause' Group and 'Drug-Induced Menopause' Group
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women (aged 18-50 y) will be enrolled. Women will be pre-menopausal, not pregnant, and not using hormone therapy or have medical indication for increased cancer risk.
Who may be able to join
- Healthy female
- Ages 18-50 y
- Planning to have either a laparoscopic bilateral oophorectomy or a laparoscopic unilateral oophorectomy (which would result in no remaining ovaries)
- 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
- Meet either of the following criteria:
- Have all 3 of the major menopause-related symptoms [hot flashes, mood swings, insomnia (trouble sleeping)]
- Have 2 of the major menopause-related symptom combinations [hot flashes and mood swings, or hot flashes and insomnia (trouble sleeping)]
- Unstable weight in the last 3 months [gain or loss >7 lb (or 3.2 kg)]
- History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
- Chronic use of systemic glucocorticoids, 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 *
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- Previous bariatric surgery (or other surgeries) for obesity or weight loss (< 3 years ago)
- 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)
- 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).
- Inconsistent use of medications listed above will be evaluated and left up to the discretion of the Medical Investigator to evaluate safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Understanding the Roles of Estradiol and Follicle-stimulating Hormone in Adipocyte Remodeling Following Surgical and Pharmacology-induced Menopause (RESUME-2 Study)
The overarching aims of this study are to:
- Characterize the rate of in vivo adipogenesis, and changes in adipose tissue gene and protein expression, in the scABD and scFEM depots of women undergoing surgical menopause (↓E2, ↑FSH).
- Characterize the rate of in vivo adipogenesis, and changes in adipose tissue gene and protein expression, in the scABD and scFEM depots of women undergoing gonadal suppression (↓E2, ↓FSH).
Read the detailed description
This is a cross-sectional study where two groups of premenopausal women (ages 18-50 y) will be enrolled in a parallel arm study:
- Arm 1 (Surgical Menopause): up to 6 women undergoing laparoscopic, elective bilateral oophorectomy [Site: Pennington Biomedical Research Center].
- Arm 2 (Pharmacology-Induced Menopause): up to 6 women undergoing gonadal suppression via leuprolide acetate (Lupron [AbbVie Inc.]) [Site: UC-Denver].
We will compare each arm of women to non-oophorectomized, premenopausal women (controls) with normal menstrual cycles (Apple\&Pear study; NCT01748994; PI: Ravussin) selectively matched (1:2) for age and BMI. The Apple\&Pear study uses the same in vivo adipogenesis labeling protocol, with similar age and BMI criteria, as the proposed study.
- Conditions
- Menopause Surgical, Estrogen Deficiency, Adiposity, Follicle-Stimulating Hormone Deficiency, Hormone Deficiency
- Being tested
- 'Surgical Menopause' Group, 'Drug-Induced Menopause' Group
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Surgical Menopause' GroupProcedure or surgery
Also called 'Bilateral Oophorectomy Surgery' Group
Women undergoing laparoscopic oophorectomy surgery ('surgical menopause') will be enrolled at Pennington Biomedical.
'Drug-Induced Menopause' GroupDrug
Also called 'Pharmacology-Induced Menopause' Group
Women undergoing gonadal suppression via leuprolide acetate (Lupron [AbbVie Inc.]) will be enrolled at the University of Colorado-Denver.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1: 'Surgical Menopause' Group | Premenopausal women having an oophorectomy. Receives: Procedure: 'Surgical Menopause' Group | |
| ARM 2: "Drug-Induced Menopause' | Premenopausal women with gonadal suppression Receives: Drug: 'Drug-Induced Menopause' Group | |
| 'Comparative (Control)' Group | Premenopausal women with regular cycles. |
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
Secondary outcomes (4)
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
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 posted27 Feb 2019
- Study start1 Apr 2019
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Why it stopped: PI left the institution.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- 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
- NCT03856268
- Sponsor's protocol ID
- PBRC 2019-010
- Acronym
- RESUME-2
- Status last verified
- Nov 2022
- First submitted
- 25 Feb 2019
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available upon request.
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
- Understanding the Roles of Estradiol and Follicle-stimulating Hormone in Adipocyte Remodeling Following Surgical and Pharmacology-induced Menopause (RESUME-2 Study)
- ClinicalTrials.gov ID
- NCT03856268
- Acronym / sponsor ID
- RESUME-2 / PBRC 2019-010
- Conditions
- Menopause Surgical, Estrogen Deficiency, Adiposity, Follicle-Stimulating Hormone Deficiency, Hormone Deficiency
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, University of Alabama at Birmingham
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 27 Feb 2019 (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 aims of this study are to:
- Characterize the rate of in vivo adipogenesis, and changes in adipose tissue gene and protein expression, in the scABD and scFEM depots of women undergoing surgical menopause (↓E2, ↑FSH).
- Characterize the rate of in vivo adipogenesis, and changes in adipose tissue gene and protein expression, in the scABD and scFEM depots of women undergoing gonadal suppression (↓E2, ↓FSH).
Detailed description
This is a cross-sectional study where two groups of premenopausal women (ages 18-50 y) will be enrolled in a parallel arm study:
- Arm 1 (Surgical Menopause): up to 6 women undergoing laparoscopic, elective bilateral oophorectomy [Site: Pennington Biomedical Research Center].
- Arm 2 (Pharmacology-Induced Menopause): up to 6 women undergoing gonadal suppression via leuprolide acetate (Lupron [AbbVie Inc.]) [Site: UC-Denver].
We will compare each arm of women to non-oophorectomized, premenopausal women (controls) with normal menstrual cycles (Apple\&Pear study; NCT01748994; PI: Ravussin) selectively matched (1:2) for age and BMI. The Apple\&Pear study uses the same in vivo adipogenesis labeling protocol, with similar age and BMI criteria, as the proposed study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM 1: 'Surgical Menopause' Group | – | Procedure: 'Surgical Menopause' GroupPremenopausal women having an oophorectomy. |
| ARM 2: "Drug-Induced Menopause' | – | Drug: 'Drug-Induced Menopause' GroupPremenopausal women with gonadal suppression |
| 'Comparative (Control)' Group | – | –Premenopausal women with regular cycles. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women (aged 18-50 y) will be enrolled. Women will be pre-menopausal, not pregnant, and not using hormone therapy or have medical indication for increased cancer risk.
Key inclusion criteria (6 listed)
- Healthy female
- Ages 18-50 y
- Planning to have either a laparoscopic bilateral oophorectomy or a laparoscopic unilateral oophorectomy (which would result in no remaining ovaries)
- 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
Key exclusion criteria (15 listed)
- Meet either of the following criteria:
- Have all 3 of the major menopause-related symptoms [hot flashes, mood swings, insomnia (trouble sleeping)]
- Have 2 of the major menopause-related symptom combinations [hot flashes and mood swings, or hot flashes and insomnia (trouble sleeping)]
- Unstable weight in the last 3 months [gain or loss >7 lb (or 3.2 kg)]
- 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 |
|---|---|---|
| 'Surgical Menopause' GroupAlso: 'Bilateral Oophorectomy Surgery' GroupWomen undergoing laparoscopic oophorectomy surgery ('surgical menopause') will be enrolled at Pennington Biomedical. | Procedure or surgery | ARM 1: 'Surgical Menopause' Group |
| 'Drug-Induced Menopause' GroupAlso: 'Pharmacology-Induced Menopause' GroupWomen undergoing gonadal suppression via leuprolide acetate (Lupron [AbbVie Inc.]) will be enrolled at the University of Colorado-Denver. | Drug | ARM 2: "Drug-Induced Menopause' |
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
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.
4 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
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 withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: Undecided. Data will be made available upon request.
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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 6 inclusion and 15 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: withdrawn, 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 withdrawn before enrolling participants, so there are no results.
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). 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.