Brain Health in Transgender Adults
2026년 5월 28일 업데이트: 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.
연구 개요
상태
모병
정황
상세 설명
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.
연구 유형
관찰
등록 (추정된)
72
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Shawn Bolin, MS
- 전화번호: 608-263-6308
- 이메일: sbolin@wisc.edu
연구 장소
-
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- 모병
- UW School of Medicine and Public Health
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
Adults (18-45 years) undergoing gender affirming hormone therapy with their clinical health care team.
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
다른 이름들:
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.
다른 이름들:
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change Cerebral Blood Flow (CBF)
기간: baseline and up to 6 months (after 4-6 months of continuous GAHT)
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CBF at rest and in response to cognitive stressors.
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Brain Structure
기간: baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
Grey matter and White matter volumes.
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Brain Connectivity
기간: baseline and up to 6 months (after 4-6 months of continuous GAHT)
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Measured using MRI.
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
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Change in Cognitive Function: Flanker Inhibitory Control and Attention
기간: 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.
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Cognitive Function: Pattern Comparison Processing Speed Test
기간: 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.
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Cognitive Function: List Sorting Working Memory Test
기간: 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.
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
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Change in Cognitive Function: Dimensional Change Card Sort Test
기간: 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
기간: 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.
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change Cerebral Blood Flow (CBF)
기간: 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
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
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Changes in sex steroid concentrations
기간: baseline and up to 6 months (after 4-6 months of continuous GAHT)
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
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Change in Body Composition
기간: baseline and up to 6 months (after 4-6 months of continuous GAHT)
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Dual-energy X-ray absorptiometry (DEXA)
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
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Change in Blood Glucose
기간: baseline and up to 6 months (after 4-6 months of continuous GAHT)
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Glucose is a marker of metabolic health
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
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Change in Insulin
기간: 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
기간: baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
Cytokines are a marker of inflammation.
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
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Optional Graded Exercise Test: VO2 Max
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: William Schrage, PhD, University of Wisconsin, Madison
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 10월 14일
기본 완료 (추정된)
2028년 4월 1일
연구 완료 (추정된)
2028년 4월 1일
연구 등록 날짜
최초 제출
2026년 5월 28일
QC 기준을 충족하는 최초 제출
2026년 5월 28일
처음 게시됨 (실제)
2026년 6월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 28일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2024-1861
- Protocol Version 1/12/26 (기타 식별자: UW Madison)
- SOE/Kinesiology (기타 식별자: UW Madison)
개별 참가자 데이터(IPD) 계획
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아니요
약물 및 장치 정보, 연구 문서
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아니
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아니
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