Brain Health in Transgender Adults
28. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Antatt)
72
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Shawn Bolin, MS
- Telefonnummer: 608-263-6308
- E-post: sbolin@wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53792
- Rekruttering
- UW School of Medicine and Public Health
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Male at birth undergoing GAHT with their Clinical Care Team
|
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 navn:
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.
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
|
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 navn:
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.
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: William Schrage, PhD, University of Wisconsin, Madison
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. oktober 2025
Primær fullføring (Antatt)
1. april 2028
Studiet fullført (Antatt)
1. april 2028
Datoer for studieregistrering
Først innsendt
28. mai 2026
Først innsendt som oppfylte QC-kriteriene
28. mai 2026
Først lagt ut (Faktiske)
3. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2024-1861
- Protocol Version 1/12/26 (Annen identifikator: UW Madison)
- SOE/Kinesiology (Annen identifikator: UW Madison)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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