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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

Primary Objective

This study is examining how gender-affirming hormone therapy affects the health of blood vessels and impacts cardiovascular disease risk in transgender women.

Study category: Diabetes & Hormone Disorders

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Description

Do you qualify? • Transgender women (i. e., assigned male at birth but identify as female) taking estradiol and spironolactone o Ages 18 to 40 or 50 to 75 years o In good general health o Have been on hormones for at least 1 year o No history of gonadectomy o No history of cancer, diabetes or heart disease o Non-smoker (or quit at least one year ago)

Main Procedures Involved: • Blood tests for hormones, cholesterol, clotting factor and other labs • Blood vessel cell collection • Dietary analysis • Physical activity monitor • Questionnaires • Ultrasound of the blood vessels • Measurements of bone mineral density and body composition • Compensation provided

Details
Age

Phase

Pilot - A pilot Study is used to obtain information, and work out the logistics and management, deemed necessary for further Research Studies.

Type of Study

Observational

Scope

Local

Compensation

Compensation provided

Locations

Anschutz Health and Wellness
Outpatient CTRC
Rocky Mountain Regional VA Medical Center
University of Colorado Hospital

Principal Investigator
Sean Iwamoto,  MD

Sean Iwamoto, MD

Study ID

Protocol Number: 18-2258

More information available at ClinicalTrials.gov: NCT04066283

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