Clinical trial NCT05195164: The Effects of Orchiectomy and Age on Vascular and Metabolic Health in Older Versus Younger Transgender Women
Official title: The Effects of Orchiectomy and Age on Vascular and Metabolic Health in Older Versus Younger Transgender Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transgender
Gender Identity
Vascular Stiffness
Vascular Inflammation
Insulin Sensitivity
Blood Pressure
Lipid Disorder
Appetitive Behavior
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-01-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transgender women from the Denver metropolitan area and/or who utilize health care at University of Colorado Hospital.

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.

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

Primary outcomes:
measure: Evaluation of endothelial function (flow-mediated dilation (FMD) at Baseline
timeFrame: Baseline
measure: Evaluation of endothelial function (flow-mediated dilation (FMD) at 1 Month
timeFrame: 1 month
measure: Evaluation of endothelial function (flow-mediated dilation (FMD) at 6 Months
timeFrame: 6 month
measure: Evaluation of endothelial function (flow-mediated dilation (FMD) at 12 Months
timeFrame: 12 month
Secondary outcomes:
measure: Evaluation of carotid artery compliance
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Evaluation of carotid artery beta stiffness index
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Carotid artery intimal-medial thickness
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Evaluation of oxidant burden: oxidized LDL
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Evaluation of oxidant burden: nitrotyrosine
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Evaluation of vascular endothelial cell inflammation: nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB)
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Evaluation of vascular endothelial cell inflammation: MCP-1
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Evaluation of vascular endothelial cell inflammation: IL-6
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Evaluation of vascular endothelial cell inflammation: CRP
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Blood pressure
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Plasma lipid concentrations: total cholesterol
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Plasma lipid concentrations: triglycerides
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Insulin sensitivity
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Whole body composition: Percent Lean Mass
timeFrame: Baseline, 6 mo., 12 mo.
measure: Whole body composition: Percent Fat Mass
timeFrame: Baseline, 6 mo., 12 mo.
measure: Regional body composition: Percent Lean Mass
timeFrame: Baseline, 6 mo., 12 mo.
measure: Regional body composition: Percent Fat Mass
timeFrame: Baseline, 6 mo., 12 mo.
measure: Bone density
timeFrame: Baseline, 12 mo.
measure: Weight changes
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Appetite ratings
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Appetite-related peptides
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: D-Dimer
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Alcohol use
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Depression symptoms
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
measure: Physical activity monitoring
timeFrame: 7 days at baseline, 1 mo., 6 mo., 12 mo.
measure: Energy intake
timeFrame: 3 days at baseline, 1 mo., 6 mo., 12 mo.
measure: Sex hormone concentrations
timeFrame: Baseline, 1 mo., 6 mo., 12 mo.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sean Iwamoto, MD
role: PRINCIPAL_INVESTIGATOR
References: