NCT04066283
Recruiting
Not Applicable
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
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 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.
Investigators
Eligibility Criteria
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
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
- Plasma lipid concentrations: total cholesterol(Baseline)
- Insulin sensitivity(Baseline)
- Whole body composition: Percent Lean Mass(Baseline)
- Evaluation of carotid artery compliance(Baseline)
- Evaluation of oxidant burden: oxidized LDL(Baseline)
- Evaluation of vascular endothelial cell inflammation: NFkB(Baseline)
- Evaluation of carotid artery beta stiffness index(Baseline)
- Weight changes(Baseline)
- Depression symptoms(Baseline)
- Carotid artery intimal-medial thickness(Baseline)
- Evaluation of vascular endothelial cell inflammation: IL-6(Baseline)
- Evaluation of vascular endothelial cell inflammation: CRP(Baseline)
- Blood pressure(Baseline)
- Evaluation of oxidant burden: nitrotyrosine(Baseline)
- Evaluation of vascular endothelial cell inflammation: MCP-1(Baseline)
- Plasma lipid concentrations: triglycerides(Baseline)
- Whole body composition: Percent Fat Mass(Baseline)
- Regional body composition: Percent Lean Mass(Baseline)
- D-Dimer(Baseline)
- Energy intake(3 days)
- Regional body composition: Percent Fat Mass(Baseline)
- Appetite ratings(Baseline)
- Appetite-related peptides(Baseline)
- Alcohol use(Baseline)
- Physical activity monitoring(7 days)
Study Sites (1)
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