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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05195164
• Other study ID #: 20-2141
• Secondary ID: NIH 5 K12 HD0570
• Status: Recruiting
• Start date: March 22, 2021
• Est. completion date: March 2024

Study information

• Verified date: March 2023
• Source: University of Colorado, Denver
• Contact: Sean Iwamoto, MD
• Phone: 303-724-8534
• Email: sean.iwamoto[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Blood Pressure
• Gender Identity
• Inflammation
• Insulin Resistance
• Insulin Sensitivity
• Lipid Disorder
• Lipid Metabolism Disorders
• Transgender
• Vascular Inflammation
• Vascular Stiffness

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of endothelial function (flow-mediated dilation (FMD) at Baseline	Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.	Baseline
Primary	Evaluation of endothelial function (flow-mediated dilation (FMD) at 1 Month	Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.	1 month
Primary	Evaluation of endothelial function (flow-mediated dilation (FMD) at 6 Months	Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.	6 month
Primary	Evaluation of endothelial function (flow-mediated dilation (FMD) at 12 Months	Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.	12 month
Secondary	Evaluation of carotid artery compliance	The carotid artery compliance index indicates how elastic the artery is. The index describes the change in arterial blood volume in response to a change in arterial blood pressure. Lower numbers are associated with worse outcomes (less elastic arteries).	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Evaluation of carotid artery beta stiffness index	The carotid artery beta stiffness index indicates how stiff the artery is. Higher numbers are associated with worse outcomes (stiffer artery).	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Carotid artery intimal-medial thickness		Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Evaluation of oxidant burden: oxidized LDL	Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Evaluation of oxidant burden: nitrotyrosine	Nitrotyrosine measured in the blood and endothelial cells.	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Evaluation of vascular endothelial cell inflammation: nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB)	Protein NFkB (nuclear factor kappa-light-chain-enhancer of activated B cells) measured in blood and endothelial cells.	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Evaluation of vascular endothelial cell inflammation: MCP-1	Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Evaluation of vascular endothelial cell inflammation: IL-6	Interleukin 6 (IL-6) measured in blood and endothelial cells.	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Evaluation of vascular endothelial cell inflammation: CRP	C-reactive protein (CRP) measured in blood and endothelial cells.	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Blood pressure	Blood pressure will be measured at baseline, 1 mo., 6 mo. 12 mo.	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Plasma lipid concentrations: total cholesterol	Total cholesterol will be determined at baseline, 1 mo., 6 mo., 12 mo.	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Plasma lipid concentrations: triglycerides	Triglycerides will be determined at baseline, 1 mo., 6 mo., 12 mo.	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Insulin sensitivity		Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Whole body composition: Percent Lean Mass	Percent lean mass will be determined using dual energy x-ray absorptiometry.	Baseline, 6 mo., 12 mo.
Secondary	Whole body composition: Percent Fat Mass	Percent fat mass will be determined using dual energy x-ray absorptiometry.	Baseline, 6 mo., 12 mo.
Secondary	Regional body composition: Percent Lean Mass	Regional percent lean mass will be determined using dual energy x-ray absorptiometry.	Baseline, 6 mo., 12 mo.
Secondary	Regional body composition: Percent Fat Mass	Regional percent fat mass will be determined using dual energy x-ray absorptiometry.	Baseline, 6 mo., 12 mo.
Secondary	Bone density	Bone density of femur and spine will be determined using dual energy x-ray absorptiometry.	Baseline, 12 mo.
Secondary	Weight changes	Body weight will be measured at baseline, 1 mo., 6 mo., 12 mo.	Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Appetite ratings		Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Appetite-related peptides		Baseline, 1 mo., 6 mo., 12 mo.
Secondary	D-Dimer		Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Alcohol use		Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Depression symptoms		Baseline, 1 mo., 6 mo., 12 mo.
Secondary	Physical activity monitoring	Physical activity will me monitored for 7 days with an ActivPAL monitor	7 days at baseline, 1 mo., 6 mo., 12 mo.
Secondary	Energy intake	Energy intake will be estimated with a 3-day food diary	3 days at baseline, 1 mo., 6 mo., 12 mo.
Secondary	Sex hormone concentrations	Sex hormone concentrations of estradiol, testosterone, follicle stimulating hormone (FSH), luteinizing hormone (LH) and sex hormone-binding globulin (SHBG) will be measured	Baseline, 1 mo., 6 mo., 12 mo.