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

NCT ID: NCT04066283

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

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-17

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 younger versus older transgender women (people who were assigned male at birth but whose gender identity is female). Data will also be compared to those from cisgender women and men.

Detailed Description

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Conditions

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Transgender Gender Identity Vascular Stiffness Vascular Inflammation Insulin Sensitivity 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 women

This cohort will consist of transgender women aged 50-75 years old who have taken estradiol and spironolactone for at least one year.

No intervention

Intervention Type OTHER

There was no intervention in this study

Younger transgender women

This cohort will consist of transgender women aged 18-40 years old who have taken estradiol and spironolactone for at least one year.

No intervention

Intervention Type OTHER

There was no intervention in this study

Interventions

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No intervention

There was no intervention in this study

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 estradiol and spironolactone for at least one year
* Currently taking oral or transdermal estradiol

Exclusion Criteria

* 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
* 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

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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18-2258

Identifier Type: -

Identifier Source: org_study_id

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