Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men

NCT ID: NCT04237467

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-29

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Transgender Gender Identity Vascular Stiffness Vascular Inflammation Blood Pressure Lipid Disorder Appetitive Behavior

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Older transgender men

This cohort will consist of transgender men aged 50-75 years old who have taken testosterone for at least one year.

No intervention

Intervention Type OTHER

There was 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.

No intervention

Intervention Type OTHER

There was no intervention.

Interventions

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No intervention

There was no intervention.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean Iwamoto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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19-2323

Identifier Type: -

Identifier Source: org_study_id

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