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Brain Health in Transgender Adults

28. maj 2026 opdateret af: University of Wisconsin, Madison

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this study is to assess the effects of GAHT on cerebral structure and function. To this end, this study has three aims:

Aim 1: To identify if transgender males and females demonstrate changes in

  • A) basal CBF and
  • B) CBF responses to acute stress-particularly in areas involved in cognition, memory, and learning.

Aim 2: To identify if transgender adults will demonstrate significant changes in:

  • A) overall brain structure,
  • B) functional connectivity, and
  • C) task activation.

Aim 3: To identify if neurocognitive function changes in transgender adults.

The investigators hypothesize that:

  • Aim 1: Transgender females will demonstrate increased basal CBF and larger CBF responses to acute stress, particularly in areas involved in cognition, memory, and learning, whereas transgender males will display lower basal CBF and lower CBF responses to acute stress.
  • Aim 2: Transgender patients will demonstrate significant changes in: a) overall brain structure, b) functional connectivity, and c) task activation.
  • Aim 3: Neurocognitive function will increase in transgender females and decreases in transgender males, primarily in the domains of memory, attention, executive function, and processing speed.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

72

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Shawn Bolin, MS
  • Telefonnummer: 608-263-6308
  • E-mail: sbolin@wisc.edu

Studiesteder

  • Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • Rekruttering
        • UW School of Medicine and Public Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults (18-45 years) undergoing gender affirming hormone therapy with their clinical health care team.

Beskrivelse

Inclusion Criteria:

  • intention to undergo GAHT

Exclusion Criteria:

  • 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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Male at birth undergoing GAHT with their Clinical Care Team
Enhed: Magnetic 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.
Andre navne:
  • MR
Andet: Cognition 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.
Andet: Optional 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.
Female at birth undergoing GAHT with their Clinical Care Team
Enhed: Magnetic 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.
Andre navne:
  • MR
Andet: Cognition 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.
Andet: Optional 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change Cerebral Blood Flow (CBF)
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
CBF at rest and in response to cognitive stressors.
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Brain Structure
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Grey matter and White matter volumes.
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Brain Connectivity
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Measured using MRI.
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cognitive Function: Flanker Inhibitory Control and Attention
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
NIH Toolbox to assess neurocognitive function. The Flanker test is a measure of executive function and is scored using a T-score where 100 is the average, higher scores indicate better performance.
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cognitive Function: Pattern Comparison Processing Speed Test
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
NIH Toolbox to assess neurocognitive function. The Pattern Comparison Processing Speed Test measures how many correct responses the participant has within 90 seconds. There is a maximum of 130 items.
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cognitive Function: List Sorting Working Memory Test
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
NIH Toolbox to assess neurocognitive function. The List Sorting Working Memory Test is a measure of recall and sorting. Participants scores reflect the number of items recalled and appropriately sorted up to 28 items maximum.
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cognitive Function: Dimensional Change Card Sort Test
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
NIH Toolbox to assess neurocognitive function. The Dimensional Change Card Sort Test measures accuracy: the number of accurate responses, up to a maximum of 40.
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cognitive Function: Picture Vocabulary Test
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
NIH Toolbox to assess neurocognitive function. The Picture Vocabulary Test has the participant hear a word and then pick from one of four pictures that best represents the word. It is scored using a T-score where 100 is the average, higher scores indicate better performance.
baseline and up to 6 months (after 4-6 months of continuous GAHT)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change Cerebral Blood Flow (CBF)
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Changes in CBF in response to inhaled mixture of room air and CO2
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Changes in sex steroid concentrations
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Body Composition
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Dual-energy X-ray absorptiometry (DEXA)
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Blood Glucose
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Glucose is a marker of metabolic health
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Insulin
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Insulin is a marker of metabolic health.
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Change in Cytokines
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
Cytokines are a marker of inflammation.
baseline and up to 6 months (after 4-6 months of continuous GAHT)
Optional Graded Exercise Test: VO2 Max
Tidsramme: baseline and up to 6 months (after 4-6 months of continuous GAHT)
An optional graded exercise test will be performed 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. This will be a ramped exercise test, starting at a wattage of 50W and increasing in difficulty by 1 watt every 2 seconds. The purpose of this is to begin at a low intensity and gradually increase the difficulty until exhaustion is reached.
baseline and up to 6 months (after 4-6 months of continuous GAHT)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Wisconsin, Madison

Efterforskere

  • Ledende efterforsker: William Schrage, PhD, University of Wisconsin, Madison

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. oktober 2025

Primær færdiggørelse (Anslået)

1. april 2028

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

28. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024-1861
  • Protocol Version 1/12/26 (Anden identifikator: UW Madison)
  • SOE/Kinesiology (Anden identifikator: UW Madison)

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