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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04237467
Other study ID # 19-2323
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 29, 2020
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
Health authority
Study type Observational

Clinical Trial Summary

This study will examine markers of vascular endothelial function (vascular health) and metabolic profiles in older versus younger transgender men (people who were assigned female at birth but whose gender identity is male). Data will also be compared to those from age group-matched transgender women and 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 testosterone for at least one year - Currently taking testosterone parenterally (injections) or transdermally (patches or gels) Exclusion Criteria: - Don't identify as a transgender man - Not currently taking testosterone - Have been on testosterone for less than one year - History of hysterectomy/oophorectomy - 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


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 Body weight 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
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