Brain Health in Transgender Adults
ConditionGender Dysphoria
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
intention to undergo GAHT
Disqualifiers
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
Trial population
Adults (18-45 years) undergoing gender affirming hormone therapy with their clinical health care team.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Magnetic Resonance Imaging
DeviceTwo 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.
Cognition and Health Tests
Other interventionTwo 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 Exercise Test
Other interventionOptional 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Male at birth undergoing GAHT with their Clinical Care Team3 interventions
Group B: Female at birth undergoing GAHT with their Clinical Care Team3 interventions
Trial outcomes
Primary outcomes
1
Change Cerebral Blood Flow (CBF)
CBF at rest and in response to cognitive stressors.
Time frame
baseline and up to 6 months (after 4-6 months of continuous GAHT)2
Change in Brain Structure
Grey matter and White matter volumes.
Time frame
baseline and up to 6 months (after 4-6 months of continuous GAHT)3
Change in Brain Connectivity
Measured using MRI.
Time frame
baseline and up to 6 months (after 4-6 months of continuous GAHT)4
Change in Cognitive Function: Flanker Inhibitory Control and Attention
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.
Time frame
baseline and up to 6 months (after 4-6 months of continuous GAHT)Secondary outcomes
1
Change Cerebral Blood Flow (CBF)
Changes in CBF in response to inhaled mixture of room air and CO2
Time frame
baseline and up to 6 months (after 4-6 months of continuous GAHT)2
Changes in sex steroid concentrations
Time frame
baseline and up to 6 months (after 4-6 months of continuous GAHT)3
Change in Body Composition
Dual-energy X-ray absorptiometry (DEXA)
Time frame
baseline and up to 6 months (after 4-6 months of continuous GAHT)4
Change in Blood Glucose
Glucose is a marker of metabolic health
Time frame
baseline and up to 6 months (after 4-6 months of continuous GAHT)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov