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RecruitingNCT07624747

Brain Health in Transgender Adults

Cerebral Blood Flow and Neurocognitive Performance in Adults Undergoing Gender-affirming Hormone Therapy

Sponsor

University of Wisconsin, Madison

Enrollment

72 participants

Start Date

Oct 14, 2025

Study Type

OBSERVATIONAL

Conditions

Gender Dysphoria

Summary

The purpose of this study is to test whether and how a person's brain changes in the first few months after starting gender affirming hormone therapy (GAHT). The investigators want to know if GAHT changes: 1) cerebral blood flow (CBF), 2) brain structure, connectivity, and cognitive task performance, and 3) neurocognitive function (memory, attention, executive function, processing speed). 36 male at birth and 36 female at birth participants will conduct baseline studies prior to GAHT, with a second identical set of study visits 4-6 months after GAHT begins.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria1

  • intention to undergo GAHT

Exclusion Criteria8

  • BMI greater than 40 kg/m2
  • Age greater than 45 yrs
  • Blood pressure greater than 140/90 (stage II hypertension)
  • A current diagnosis of type II diabetes
  • History of traumatic brain injury/concussion, stroke, or seizures
  • Are post-menopausal
  • Previously taken hormone therapy medications
  • Self-reported pregnancy (no pregnancy test)

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Interventions

DEVICEMagnetic Resonance Imaging

Two MRI visits (baseline and after 4-6 months of continuous GAHT) will involve structural scans of the brain, scans while performing cognitive tasks, and a scan taken while responding to an inhaled CO2 stressor. This visit will take approximately 1.5 hours.

OTHERCognition and Health Tests

Two cognition and health test trials (baseline and after 4-6 months of continuous GAHT) will involve a body composition scan to determine body fat percentage, muscle mass, and bone density. This will be followed by a set of cognitive tasks using the NIH Toolbox.

OTHEROptional Exercise Test

Optional graded exercise test will be performed if the participant consents to this optional procedure (baseline and after 4-6months of continuous GAHT). to determine cardiorespiratory fitness. This test will be performed on a cycle ergometer, with a metabolic allowing for the measurement of maximal oxygen consumption via indirect calorimetry.

Locations(1)

UW School of Medicine and Public Health

Madison, Wisconsin, United States

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