TransgenderNCT05195164
The Effects of Orchiectomy and Age on Vascular and Metabolic Health in Older Versus Younger Transgender Women
An observational study of Transgender and Gender Identity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about differences in heart disease risk after gender-affirming orchiectomy (i.e., testes removal) in older transgender (trans) women compared to younger trans women. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Transgender, Gender Identity, Vascular Stiffness
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 31 Dec 2023
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Transgender women from the Denver metropolitan area and/or who utilize health care at University of Colorado Hospital.
Who may be able to join
- Aged 18 years and older
- Identify as a transgender woman
- Have taken estradiol and spironolactone for at least one year
- Currently taking oral or transdermal or injectable estradiol
- Have not yet undergone but desire orchiectomy
Who cannot join
- Under 18 years of age
- Don't identify as a transgender woman
- Not currently taking estradiol or spironolactone
- Have been on estradiol and spironolactone for less than one year
- History of orchiectomy
- Not deemed a candidate for orchiectomy
Show all 14Show fewer
- Current tobacco smoker
- Current illicit drug use
- History of prior or active estrogen-dependent neoplasms
- Acute liver or gallbladder disease
- Venous thromboembolism
- Hypertriglyceridemia >500 mg/dL
- Fasted plasma glucose >7.0 mmol/L or previously treated diabetes
- Resting blood pressure >140/90 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
This study plans to learn more about differences in heart disease risk after gender-affirming orchiectomy (i.e., testes removal) in older transgender (trans) women compared to younger trans women.
Read the detailed description
The global aim of this study is to characterize cardiometabolic risk (measured by vascular, metabolic and biochemical factors-which have not been extensively studied prospectively) in trans women before and after orchiectomy. Trans women appear to be at greater risk for cardiovascular disease (CVD) and blood clots compared to non-trans adults. The effect of orchiectomy on CVD risk among trans women is unknown, but orchiectomy may change blood vessel function and metabolic health. The investigators will examine blood vessel function and metabolic profiles of trans women before and at several timepoints after orchiectomy to identify age-related differences in CVD risk factors. This knowledge may lead to new approaches to prevent CVD in trans women as well as all people regardless of gender identity.
- Conditions
- Transgender, Gender Identity, Vascular Stiffness, Vascular Inflammation, Insulin Sensitivity, Blood Pressure
- Being tested
- No intervention
- Medical subject headings
- Insulin Resistance, Lipid Metabolism Disorders, Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There was no intervention
| Study group | Role | What they receive |
|---|---|---|
| Older transgender women | This cohort will consist of healthy transgender women aged 45 and above who have not undergone but desire orchiectomy, who have been on estrogen (history of oral, transdermal or injectable) and spironolactone for at least one year. Receives: Other: No intervention | |
| Younger transgender women | This cohort will consist of healthy transgender women aged 18-44 who have not undergone but desire orchiectomy, who have been on estrogen (history of oral, transdermal or injectable) and spironolactone for at least one year. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of endothelial function (flow-mediated dilation (FMD) at Baseline
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Measured: Baseline
Evaluation of endothelial function (flow-mediated dilation (FMD) at 1 Month
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Measured: 1 month
Evaluation of endothelial function (flow-mediated dilation (FMD) at 6 Months
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Measured: 6 month
Evaluation of endothelial function (flow-mediated dilation (FMD) at 12 Months
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Measured: 12 month
Secondary outcomes (27)
Evaluation of carotid artery compliance
The carotid artery compliance index indicates how elastic the artery is. The index describes the change in arterial blood volume in response to a change in arterial blood pressure. Lower numbers are associated with worse outcomes (less elastic arteries).
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of carotid artery beta stiffness index
The carotid artery beta stiffness index indicates how stiff the artery is. Higher numbers are associated with worse outcomes (stiffer artery).
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Carotid artery intimal-medial thickness
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of oxidant burden: oxidized LDL
Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of oxidant burden: nitrotyrosine
Nitrotyrosine measured in the blood and endothelial cells.
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of vascular endothelial cell inflammation: nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB)
Protein NFkB (nuclear factor kappa-light-chain-enhancer of activated B cells) measured in blood and endothelial cells.
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of vascular endothelial cell inflammation: MCP-1
Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of vascular endothelial cell inflammation: IL-6
Interleukin 6 (IL-6) measured in blood and endothelial cells.
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of vascular endothelial cell inflammation: CRP
C-reactive protein (CRP) measured in blood and endothelial cells.
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Blood pressure
Blood pressure will be measured at baseline, 1 mo., 6 mo. 12 mo.
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Plasma lipid concentrations: total cholesterol
Total cholesterol will be determined at baseline, 1 mo., 6 mo., 12 mo.
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Plasma lipid concentrations: triglycerides
Triglycerides will be determined at baseline, 1 mo., 6 mo., 12 mo.
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Insulin sensitivity
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Whole body composition: Percent Lean Mass
Percent lean mass will be determined using dual energy x-ray absorptiometry.
Measured: Baseline, 6 mo., 12 mo.
Whole body composition: Percent Fat Mass
Percent fat mass will be determined using dual energy x-ray absorptiometry.
Measured: Baseline, 6 mo., 12 mo.
Regional body composition: Percent Lean Mass
Regional percent lean mass will be determined using dual energy x-ray absorptiometry.
Measured: Baseline, 6 mo., 12 mo.
Regional body composition: Percent Fat Mass
Regional percent fat mass will be determined using dual energy x-ray absorptiometry.
Measured: Baseline, 6 mo., 12 mo.
Bone density
Bone density of femur and spine will be determined using dual energy x-ray absorptiometry.
Measured: Baseline, 12 mo.
Weight changes
Body weight will be measured at baseline, 1 mo., 6 mo., 12 mo.
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Appetite ratings
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Appetite-related peptides
Measured: Baseline, 1 mo., 6 mo., 12 mo.
D-Dimer
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Alcohol use
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Depression symptoms
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Physical activity monitoring
Physical activity will me monitored for 7 days with an ActivPAL monitor
Measured: 7 days at baseline, 1 mo., 6 mo., 12 mo.
Energy intake
Energy intake will be estimated with a 3-day food diary
Measured: 3 days at baseline, 1 mo., 6 mo., 12 mo.
Sex hormone concentrations
Sex hormone concentrations of estradiol, testosterone, follicle stimulating hormone (FSH), luteinizing hormone (LH) and sex hormone-binding globulin (SHBG) will be measured
Measured: Baseline, 1 mo., 6 mo., 12 mo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start22 Mar 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Sean Iwamoto, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195164
- Sponsor's protocol ID
- 20-2141
- Other IDs
- NIH 5 K12 HD057022
- Status last verified
- Sep 2024
- First submitted
- 22 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Orchiectomy and Age on Vascular and Metabolic Health in Older Versus Younger Transgender Women
- ClinicalTrials.gov ID
- NCT05195164
- Acronym / sponsor ID
- 20-2141
- Conditions
- Transgender, Gender Identity, Vascular Stiffness, Vascular Inflammation, Insulin Sensitivity, Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Jan 2022 (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.
This study plans to learn more about differences in heart disease risk after gender-affirming orchiectomy (i.e., testes removal) in older transgender (trans) women compared to younger trans women.
Detailed description
The global aim of this study is to characterize cardiometabolic risk (measured by vascular, metabolic and biochemical factors-which have not been extensively studied prospectively) in trans women before and after orchiectomy. Trans women appear to be at greater risk for cardiovascular disease (CVD) and blood clots compared to non-trans adults. The effect of orchiectomy on CVD risk among trans women is unknown, but orchiectomy may change blood vessel function and metabolic health. The investigators will examine blood vessel function and metabolic profiles of trans women before and at several timepoints after orchiectomy to identify age-related differences in CVD risk factors. This knowledge may lead to new approaches to prevent CVD in trans women as well as all people regardless of gender identity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older transgender women | – | Other: No interventionThis cohort will consist of healthy transgender women aged 45 and above who have not undergone but desire orchiectomy, who have been on estrogen (history of oral, transdermal or injectable) and spironolactone for at least one year. |
| Younger transgender women | – | Other: No interventionThis cohort will consist of healthy transgender women aged 18-44 who have not undergone but desire orchiectomy, who have been on estrogen (history of oral, transdermal or injectable) and spironolactone for at least one year. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Transgender women from the Denver metropolitan area and/or who utilize health care at University of Colorado Hospital.
Key inclusion criteria (5 listed)
- Aged 18 years and older
- Identify as a transgender woman
- Have taken estradiol and spironolactone for at least one year
- Currently taking oral or transdermal or injectable estradiol
- Have not yet undergone but desire orchiectomy
Key exclusion criteria (14 listed)
- Under 18 years of age
- Don't identify as a transgender woman
- Not currently taking estradiol or spironolactone
- Have been on estradiol and spironolactone for less than one year
- History of orchiectomy
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 |
|---|---|---|
| No interventionThere was no intervention | Other | Older transgender women, Younger transgender women |
Primary outcome
Evaluation of endothelial function (flow-mediated dilation (FMD) at Baseline
Time frame: Baseline
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Evaluation of endothelial function (flow-mediated dilation (FMD) at 1 Month
Time frame: 1 month
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Evaluation of endothelial function (flow-mediated dilation (FMD) at 6 Months
Time frame: 6 month
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Evaluation of endothelial function (flow-mediated dilation (FMD) at 12 Months
Time frame: 12 month
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
27 secondary outcomes
Evaluation of carotid artery compliance
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of carotid artery beta stiffness index
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Carotid artery intimal-medial thickness
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of oxidant burden: oxidized LDL
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of oxidant burden: nitrotyrosine
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of vascular endothelial cell inflammation: nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB)
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of vascular endothelial cell inflammation: MCP-1
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of vascular endothelial cell inflammation: IL-6
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Evaluation of vascular endothelial cell inflammation: CRP
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Blood pressure
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Plasma lipid concentrations: total cholesterol
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Plasma lipid concentrations: triglycerides
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Insulin sensitivity
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Whole body composition: Percent Lean Mass
Time frame: Baseline, 6 mo., 12 mo.
Whole body composition: Percent Fat Mass
Time frame: Baseline, 6 mo., 12 mo.
Regional body composition: Percent Lean Mass
Time frame: Baseline, 6 mo., 12 mo.
Regional body composition: Percent Fat Mass
Time frame: Baseline, 6 mo., 12 mo.
Bone density
Time frame: Baseline, 12 mo.
Weight changes
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Appetite ratings
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Appetite-related peptides
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
D-Dimer
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Alcohol use
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Depression symptoms
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Physical activity monitoring
Time frame: 7 days at baseline, 1 mo., 6 mo., 12 mo.
Energy intake
Time frame: 3 days at baseline, 1 mo., 6 mo., 12 mo.
Sex hormone concentrations
Time frame: Baseline, 1 mo., 6 mo., 12 mo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Sean Iwamoto, MD principal investigator
University of Colorado, Denver
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 Transgender and Gender Identity, run by University of Colorado, Denver 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of endothelial function (flow-mediated dilation (FMD) at Baseline (time frame: Baseline). The study lists 4 primary outcomes in all. 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 19 Sep 2024.