The Effects of Orchiectomy and Age on Vascular and Metabolic Health in Older Versus Younger Transgender Women

NCT ID: NCT05195164

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2023-12-31

Brief 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.

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; Lipid Disorder; Appetitive Behavior

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No intervention

Intervention Type: OTHER

There was 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.

No intervention

Intervention Type: OTHER

There was no intervention

Interventions

No intervention

There was no intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Iwamoto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

NIH 5 K12 HD057022

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20-2141

Identifier Type: -

Identifier Source: org_study_id