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Brain Health in Transgender Adults

28. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

72

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studienorte

  • Vereinigte Staaten
    • Wisconsin
      • Madison, Wisconsin, Vereinigte Staaten, 53792
        • Rekrutierung
        • UW School of Medicine and Public Health

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Male at birth undergoing GAHT with their Clinical Care Team
Gerät: 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.
Andere Namen:
  • MRT
Sonstiges: 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.
Sonstiges: 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
Gerät: 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.
Andere Namen:
  • MRT
Sonstiges: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change Cerebral Blood Flow (CBF)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change Cerebral Blood Flow (CBF)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Wisconsin, Madison

Ermittler

  • Hauptermittler: William Schrage, PhD, University of Wisconsin, Madison

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

14. Oktober 2025

Primärer Abschluss (Geschätzt)

1. April 2028

Studienabschluss (Geschätzt)

1. April 2028

Studienanmeldedaten

Zuerst eingereicht

28. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Mai 2026

Zuerst gepostet (Tatsächlich)

3. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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