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

Blood Pressure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066283
• Other study ID #: 18-2258
• Status: Recruiting
• Start date: April 17, 2019
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Sean Iwamoto, MD
• Phone: 303-724-3662
• Email: sean.iwamoto[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

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)	Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.	Baseline
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
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
Secondary	Carotid artery intimal-medial thickness		Baseline
Secondary	Evaluation of oxidant burden: oxidized LDL	Oxidized low-density lipoprotein (LDL) measured in the blood and endothelial cells.	Baseline
Secondary	Evaluation of oxidant burden: nitrotyrosine	Nitrotyrosine measured in the blood and endothelial cells.	Baseline
Secondary	Evaluation of vascular endothelial cell inflammation: NFkB	Protein NFkB (nuclear factor kappa-light-chain-enhancer of activated B cells) measured in blood and endothelial cells.	Baseline
Secondary	Evaluation of vascular endothelial cell inflammation: MCP-1	Monocyte Chemoattractant Protein-1 (MCP-1) measured in blood and endothelial cells.	Baseline
Secondary	Evaluation of vascular endothelial cell inflammation: IL-6	Interleukin 6 (IL-6) measured in blood and endothelial cells.	Baseline
Secondary	Evaluation of vascular endothelial cell inflammation: CRP	C-reactive protein (CRP) measured in blood and endothelial cells.	Baseline
Secondary	Blood pressure		Baseline
Secondary	Plasma lipid concentrations: total cholesterol	Total cholesterol will be determined at baseline.	Baseline
Secondary	Plasma lipid concentrations: triglycerides	Triglycerides will be determined at baseline.	Baseline
Secondary	Insulin sensitivity		Baseline
Secondary	Whole body composition: Percent Lean Mass	Percent lean mass will be determined using dual energy x-ray absorptiometry.	Baseline
Secondary	Whole body composition: Percent Fat Mass	Percent fat mass will be determined using dual energy x-ray absorptiometry.	Baseline
Secondary	Regional body composition: Percent Lean Mass	Regional percent lean mass will be determined using dual energy x-ray absorptiometry.	Baseline
Secondary	Regional body composition: Percent Fat Mass	Regional percent fat mass will be determined using dual energy x-ray absorptiometry.	Baseline
Secondary	Weight changes		Baseline
Secondary	Appetite ratings		Baseline
Secondary	Appetite-related peptides		Baseline
Secondary	D-Dimer		Baseline
Secondary	Alcohol use		Baseline
Secondary	Depression symptoms		Baseline
Secondary	Physical activity monitoring	Physical activity will me monitored for 7 days with an ActivPALmonitor	7 days
Secondary	Energy intake	Energy intake will be estimated with a 3-day food diary	3 days