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

Recruiting

• Conditions: Gender Identity; Transgender; Vascular Stiffness; Blood Pressure; Lipid Disorder; Appetitive Behavior; Insulin Sensitivity; Vascular Inflammation
• Interventions: Other: No intervention

• Registration Number: NCT04066283
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-17
• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-04
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Older transgender women	No intervention	This cohort will consist of transgender women aged 50-75 years old who have taken estradiol and spironolactone for at least one year.
Younger transgender women	No intervention	This cohort will consist of transgender women aged 18-40 years old who have taken estradiol and spironolactone for at least one year.

Primary Outcome Measures

Name	Time	Method
Evaluation of endothelial function (flow-mediated dilation (FMD)	Baseline	Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States