NCT04237467
Recruiting
Not Applicable
Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Men Compared to Age Group-Matched Transgender Women and Cisgender Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transgender
- Sponsor
- University of Colorado, Denver
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Evaluation of endothelial function (flow-mediated dilation (FMD)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Evaluation of endothelial function (flow-mediated dilation (FMD)
Time Frame: Baseline
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Secondary Outcomes
- Alcohol use(Baseline)
- Plasma lipid concentrations: total cholesterol(Baseline)
- Evaluation of oxidant burden: nitrotyrosine(Baseline)
- Evaluation of carotid artery compliance(Baseline)
- Evaluation of carotid artery beta stiffness index(Baseline)
- Carotid artery intimal-medial thickness(Baseline)
- Evaluation of oxidant burden: oxidized LDL(Baseline)
- Appetite ratings(Baseline)
- Evaluation of vascular endothelial cell inflammation: MCP-1(Baseline)
- Evaluation of vascular endothelial cell inflammation: CRP(Baseline)
- Insulin sensitivity(Baseline)
- Whole body composition: Percent Lean Mass(Baseline)
- Body weight(Baseline)
- Depression symptoms(Baseline)
- Physical activity monitoring(7 days)
- Plasma lipid concentrations: triglycerides(Baseline)
- Regional body composition: Percent Lean Mass(Baseline)
- Evaluation of vascular endothelial cell inflammation: NFkB(Baseline)
- Appetite-related peptides(Baseline)
- D-Dimer(Baseline)
- Regional body composition: Percent Fat Mass(Baseline)
- Evaluation of vascular endothelial cell inflammation: IL-6(Baseline)
- Blood pressure(Baseline)
- Whole body composition: Percent Fat Mass(Baseline)
- Energy intake(3 days)
Study Sites (1)
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