TransgenderNCT04237467
Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men
An observational study of Transgender and Gender Identity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will examine markers of vascular endothelial function (vascular health) and metabolic profiles in older versus younger transgender men (people who were assigned female at birth but whose gender identity is male). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Transgender, Gender Identity, Vascular Stiffness
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2020to 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Transgender men from the Denver metropolitan area and/or who utilize health care at University of Colorado Hospital.
Who may be able to join
- Aged 18-40 years old or 50-75 years old
- Identify as a transgender woman
- Have taken testosterone for at least one year
- Currently taking testosterone parenterally (injections) or transdermally (patches or gels)
Who cannot join
- Don't identify as a transgender man
- Not currently taking testosterone
- Have been on testosterone for less than one year
- History of hysterectomy/oophorectomy
- Current tobacco smoker
- Current illicit drug use
Show all 12Show fewer
- 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
Official title: Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults
This study will examine markers of vascular endothelial function (vascular health) and metabolic profiles in older versus younger transgender men (people who were assigned female at birth but whose gender identity is male). Data will also be compared to those from age group-matched transgender women and cisgender women and men.
- Conditions
- Transgender, Gender Identity, Vascular Stiffness, Vascular Inflammation, Blood Pressure, Lipid Disorder
- Being tested
- No intervention
- Medical subject headings
- 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 men | This cohort will consist of transgender men aged 50-75 years old who have taken testosterone for at least one year. Receives: Other: No intervention | |
| Younger transgender men | This cohort will consist of transgender men aged 18-40 years old who have taken testosterone 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)
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Measured: Baseline
Secondary outcomes (25)
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
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
Carotid artery intimal-medial thickness
Measured: Baseline
Evaluation of oxidant burden: oxidized LDL
Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.
Measured: Baseline
Evaluation of oxidant burden: nitrotyrosine
Nitrotyrosine measured in the blood and endothelial cells.
Measured: Baseline
Evaluation of vascular endothelial cell inflammation: NFkB
Protein NFkB (nuclear factor kappa-light-chain-enhancer of activated B cells) measured in blood and endothelial cells.
Measured: Baseline
Evaluation of vascular endothelial cell inflammation: MCP-1
Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.
Measured: Baseline
Evaluation of vascular endothelial cell inflammation: IL-6
Interleukin 6 (IL-6) measured in blood and endothelial cells.
Measured: Baseline
Evaluation of vascular endothelial cell inflammation: CRP
C-reactive protein (CRP) measured in blood and endothelial cells.
Measured: Baseline
Blood pressure
Measured: Baseline
Plasma lipid concentrations: total cholesterol
Total cholesterol will be determined at baseline.
Measured: Baseline
Plasma lipid concentrations: triglycerides
Triglycerides will be determined at baseline.
Measured: Baseline
Insulin sensitivity
Measured: Baseline
Whole body composition: Percent Lean Mass
Percent lean mass will be determined using dual energy x-ray absorptiometry.
Measured: Baseline
Whole body composition: Percent Fat Mass
Percent fat mass will be determined using dual energy x-ray absorptiometry.
Measured: Baseline
Regional body composition: Percent Lean Mass
Regional percent lean mass will be determined using dual energy x-ray absorptiometry.
Measured: Baseline
Regional body composition: Percent Fat Mass
Regional percent fat mass will be determined using dual energy x-ray absorptiometry.
Measured: Baseline
Body weight
Measured: Baseline
Appetite ratings
Measured: Baseline
Appetite-related peptides
Measured: Baseline
D-Dimer
Measured: Baseline
Alcohol use
Measured: Baseline
Depression symptoms
Measured: Baseline
Physical activity monitoring
Physical activity will me monitored for 7 days with an ActivPALmonitor
Measured: 7 days
Energy intake
Energy intake will be estimated with a 3-day food diary
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start29 Jan 2020
- 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
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Sean Iwamoto, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237467
- Sponsor's protocol ID
- 19-2323
- Status last verified
- Sep 2024
- First submitted
- 17 Jan 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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
- Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults
- ClinicalTrials.gov ID
- NCT04237467
- Acronym / sponsor ID
- 19-2323
- Conditions
- Transgender, Gender Identity, Vascular Stiffness, Vascular Inflammation, Blood Pressure, Lipid Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Jan 2020 (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 will examine markers of vascular endothelial function (vascular health) and metabolic profiles in older versus younger transgender men (people who were assigned female at birth but whose gender identity is male). Data will also be compared to those from age group-matched transgender women and cisgender women and men.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older transgender men | – | Other: No interventionThis cohort will consist of transgender men aged 50-75 years old who have taken testosterone for at least one year. |
| Younger transgender men | – | Other: No interventionThis cohort will consist of transgender men aged 18-40 years old who have taken testosterone for at least one year. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Transgender men from the Denver metropolitan area and/or who utilize health care at University of Colorado Hospital.
Key inclusion criteria (4 listed)
- Aged 18-40 years old or 50-75 years old
- Identify as a transgender woman
- Have taken testosterone for at least one year
- Currently taking testosterone parenterally (injections) or transdermally (patches or gels)
Key exclusion criteria (12 listed)
- Don't identify as a transgender man
- Not currently taking testosterone
- Have been on testosterone for less than one year
- History of hysterectomy/oophorectomy
- Current tobacco smoker
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 men, Younger transgender men |
Primary outcome
Evaluation of endothelial function (flow-mediated dilation (FMD)
Time frame: Baseline
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
25 secondary outcomes
Evaluation of carotid artery compliance
Time frame: Baseline
Evaluation of carotid artery beta stiffness index
Time frame: Baseline
Carotid artery intimal-medial thickness
Time frame: Baseline
Evaluation of oxidant burden: oxidized LDL
Time frame: Baseline
Evaluation of oxidant burden: nitrotyrosine
Time frame: Baseline
Evaluation of vascular endothelial cell inflammation: NFkB
Time frame: Baseline
Evaluation of vascular endothelial cell inflammation: MCP-1
Time frame: Baseline
Evaluation of vascular endothelial cell inflammation: IL-6
Time frame: Baseline
Evaluation of vascular endothelial cell inflammation: CRP
Time frame: Baseline
Blood pressure
Time frame: Baseline
Plasma lipid concentrations: total cholesterol
Time frame: Baseline
Plasma lipid concentrations: triglycerides
Time frame: Baseline
Insulin sensitivity
Time frame: Baseline
Whole body composition: Percent Lean Mass
Time frame: Baseline
Whole body composition: Percent Fat Mass
Time frame: Baseline
Regional body composition: Percent Lean Mass
Time frame: Baseline
Regional body composition: Percent Fat Mass
Time frame: Baseline
Body weight
Time frame: Baseline
Appetite ratings
Time frame: Baseline
Appetite-related peptides
Time frame: Baseline
D-Dimer
Time frame: Baseline
Alcohol use
Time frame: Baseline
Depression symptoms
Time frame: Baseline
Physical activity monitoring
Time frame: 7 days
Energy intake
Time frame: 3 days
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 4 inclusion and 12 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) (time frame: Baseline). 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.