Brain Health in Transgender Adults
28 maj 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
72
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Shawn Bolin, MS
- Telefonnummer: 608-263-6308
- E-post: sbolin@wisc.edu
Studieorter
-
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Wisconsin
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Madison, Wisconsin, Förenta staterna, 53792
- Rekrytering
- UW School of Medicine and Public Health
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adults (18-45 years) undergoing gender affirming hormone therapy with their clinical health care team.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
Andra namn:
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.
Andra namn:
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change Cerebral Blood Flow (CBF)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change Cerebral Blood Flow (CBF)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
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Change in Insulin
Tidsram: baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
Insulin is a marker of metabolic health.
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Cytokines
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: William Schrage, PhD, University of Wisconsin, Madison
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
14 oktober 2025
Primärt slutförande (Beräknad)
1 april 2028
Avslutad studie (Beräknad)
1 april 2028
Studieregistreringsdatum
Först inskickad
28 maj 2026
Först inskickad som uppfyllde QC-kriterierna
28 maj 2026
Första postat (Faktisk)
3 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024-1861
- Protocol Version 1/12/26 (Annan identifierare: UW Madison)
- SOE/Kinesiology (Annan identifierare: UW Madison)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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