- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04237467
Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men
November 28, 2023 updated by: University of Colorado, Denver
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.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gebregzabheir
- Email: amanuail.gebregzabheir@cuanschutz.edu
Study Contact Backup
- Name: Sean Iwamoto, MD
- Phone Number: 303-724-3662
- Email: sean.iwamoto@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado
-
Contact:
- Amanuail Gebregzabheir
- Email: amanuail.gebregzabheir@cuanschutz.edu
-
Contact:
- Sean Iwamoto, MD
- Phone Number: 303-724-3662
- Email: sean.iwamoto@cuanschutz.edu
-
Principal Investigator:
- Sean Iwamoto, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Transgender men from the Denver metropolitan area and/or who utilize health care at University of Colorado Hospital.
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
Older transgender men
This cohort will consist of transgender men aged 50-75 years old who have taken testosterone for at least one year.
|
Younger transgender men
This cohort will consist of transgender men aged 18-40 years old who have taken testosterone for at least one year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of endothelial function (flow-mediated dilation (FMD)
Time Frame: Baseline
|
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin sensitivity
Time Frame: Baseline
|
Baseline
|
|
Alcohol use
Time Frame: Baseline
|
Baseline
|
|
Blood pressure
Time Frame: Baseline
|
Baseline
|
|
Evaluation of carotid artery compliance
Time Frame: Baseline
|
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).
|
Baseline
|
Evaluation of carotid artery beta stiffness index
Time Frame: Baseline
|
The carotid artery beta stiffness index indicates how stiff the artery is.
Higher numbers are associated with worse outcomes (stiffer artery)
|
Baseline
|
Carotid artery intimal-medial thickness
Time Frame: Baseline
|
Baseline
|
|
Evaluation of oxidant burden: oxidized LDL
Time Frame: Baseline
|
Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.
|
Baseline
|
Evaluation of oxidant burden: nitrotyrosine
Time Frame: Baseline
|
Nitrotyrosine measured in the blood and endothelial cells.
|
Baseline
|
Evaluation of vascular endothelial cell inflammation: NFkB
Time Frame: Baseline
|
Protein NFkB (nuclear factor kappa-light-chain-enhancer of activated B cells) measured in blood and endothelial cells.
|
Baseline
|
Evaluation of vascular endothelial cell inflammation: MCP-1
Time Frame: Baseline
|
Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.
|
Baseline
|
Evaluation of vascular endothelial cell inflammation: IL-6
Time Frame: Baseline
|
Interleukin 6 (IL-6) measured in blood and endothelial cells.
|
Baseline
|
Evaluation of vascular endothelial cell inflammation: CRP
Time Frame: Baseline
|
C-reactive protein (CRP) measured in blood and endothelial cells.
|
Baseline
|
Plasma lipid concentrations: total cholesterol
Time Frame: Baseline
|
Total cholesterol will be determined at baseline.
|
Baseline
|
Plasma lipid concentrations: triglycerides
Time Frame: Baseline
|
Triglycerides will be determined at baseline.
|
Baseline
|
Whole body composition: Percent Lean Mass
Time Frame: Baseline
|
Percent lean mass will be determined using dual energy x-ray absorptiometry.
|
Baseline
|
Whole body composition: Percent Fat Mass
Time Frame: Baseline
|
Percent fat mass will be determined using dual energy x-ray absorptiometry.
|
Baseline
|
Regional body composition: Percent Lean Mass
Time Frame: Baseline
|
Regional percent lean mass will be determined using dual energy x-ray absorptiometry.
|
Baseline
|
Regional body composition: Percent Fat Mass
Time Frame: Baseline
|
Regional percent fat mass will be determined using dual energy x-ray absorptiometry.
|
Baseline
|
Body weight
Time Frame: Baseline
|
Baseline
|
|
Appetite ratings
Time Frame: Baseline
|
Baseline
|
|
Appetite-related peptides
Time Frame: Baseline
|
Baseline
|
|
D-Dimer
Time Frame: Baseline
|
Baseline
|
|
Depression symptoms
Time Frame: Baseline
|
Baseline
|
|
Physical activity monitoring
Time Frame: 7 days
|
Physical activity will me monitored for 7 days with an ActivPALmonitor
|
7 days
|
Energy intake
Time Frame: 3 days
|
Energy intake will be estimated with a 3-day food diary
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sean Iwamoto, MD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2020
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
November 1, 2024
Study Registration Dates
First Submitted
January 17, 2020
First Submitted That Met QC Criteria
January 17, 2020
First Posted (Actual)
January 23, 2020
Study Record Updates
Last Update Posted (Estimated)
December 4, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-2323
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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