Clinical trial NCT04066283: Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women
Official title: Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women Compared to Age Group-Matched Cisgender Adults
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: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-08-26
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of endothelial function (flow-mediated dilation (FMD)
timeFrame: Baseline
Secondary outcomes:
measure: Evaluation of carotid artery compliance
timeFrame: Baseline
measure: Evaluation of carotid artery beta stiffness index
timeFrame: Baseline
measure: Carotid artery intimal-medial thickness
timeFrame: Baseline
measure: Evaluation of oxidant burden: oxidized LDL
timeFrame: Baseline
measure: Evaluation of oxidant burden: nitrotyrosine
timeFrame: Baseline
measure: Evaluation of vascular endothelial cell inflammation: NFkB
timeFrame: Baseline
measure: Evaluation of vascular endothelial cell inflammation: MCP-1
timeFrame: Baseline
measure: Evaluation of vascular endothelial cell inflammation: IL-6
timeFrame: Baseline
measure: Evaluation of vascular endothelial cell inflammation: CRP
timeFrame: Baseline
measure: Blood pressure
timeFrame: Baseline
measure: Plasma lipid concentrations: total cholesterol
timeFrame: Baseline
measure: Plasma lipid concentrations: triglycerides
timeFrame: Baseline
measure: Insulin sensitivity
timeFrame: Baseline
measure: Whole body composition: Percent Lean Mass
timeFrame: Baseline
measure: Whole body composition: Percent Fat Mass
timeFrame: Baseline
measure: Regional body composition: Percent Lean Mass
timeFrame: Baseline
measure: Regional body composition: Percent Fat Mass
timeFrame: Baseline
measure: Weight changes
timeFrame: Baseline
measure: Appetite ratings
timeFrame: Baseline
measure: Appetite-related peptides
timeFrame: Baseline
measure: D-Dimer
timeFrame: Baseline
measure: Alcohol use
timeFrame: Baseline
measure: Depression symptoms
timeFrame: Baseline
measure: Physical activity monitoring
timeFrame: 7 days
measure: Energy intake
timeFrame: 3 days
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: