Brain Health in Transgender Adults

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Change Cerebral Blood Flow (CBF) [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Change in Brain Structure [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Change in Brain Connectivity [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Change in Cognitive Function: Flanker Inhibitory Control and Attention [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Change in Cognitive Function: Pattern Comparison Processing Speed Test [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Change in Cognitive Function: List Sorting Working Memory Test [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Change in Cognitive Function: Dimensional Change Card Sort Test [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Change in Cognitive Function: Picture Vocabulary Test [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]

Вторичные конечные точки (7)

• Change Cerebral Blood Flow (CBF) [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Changes in sex steroid concentrations [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Change in Body Composition [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Change in Blood Glucose [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Change in Insulin [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Change in Cytokines [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]
• Optional Graded Exercise Test: VO2 Max [Срок оценки: baseline and up to 6 months (after 4-6 months of continuous GAHT)]

Критерии участия

Критерии включения

• intention to undergo GAHT

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• UW School of Medicine and Public Health — Madison

Идентификаторы

NCT: NCT07624747 · 2024-1861 · Protocol Version 1/12/26 · SOE/Kinesiology

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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