Effects of Gender-Affirming Hormone Therapy Among Transgender Women

Study Overview
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Brief Summary
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In this study, investigators plan to evaluate the cardiometabolic effects of initiating gender-affirming hormone therapy among transgender women with and without HIV. As part of this study, participants will undergo cardiovascular and metabolic phenotyping within 3 months of starting and after 12 months of gender-affirming hormone therapy. Cardiovascular phenotyping will include cardiac MRI/MRS imaging to evaluate cardiac function and structure. Metabolic phenotyping will include oral glucose tolerance testing, abdominal MR imaging to evaluate visceral adiposity, and whole body, lumbar, and hip DEXA imaging to evaluate fat and lean body mass as well as bone mineral density, respectively. Traditional markers of CVD risk as well as immune, hormonal, and coagulation parameters will also be assessed longitudinally.

Official Title
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Effects of Gender-Affirming Hormone Therapy Among Transgender Women

Conditions
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Transgender Women, HIV/AIDS, Cardiovascular Diseases, Metabolic Disease, Coagulopathy

Intervention / Treatment
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* Other: Abdominal MR Imaging
* Other: Cardiac MRI/MRS
* Other: Oral Glucose Tolerance Testing
* Other: Whole Body, Lumbar Spine, and Hip DEXA Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: transgender women or non-binary individual age ≥16 For women with HIV only: on ART therapy for ≥3 months initiation of testosterone suppression with spironolactone or leuprolide and estrogen therapy with oral 17-β estradiol, transdermal 17β estradiol, sublingual estradiol, intramuscular estradiol, or subcutaneous estradiol by medical provider Exclusion Criteria: For women with HIV only: CD4 count<50 history of CAD, ACS, ASCVD risk score ≥ 7.5%, LDL-C ≥ 190, or angina (e.g. current indication for statin use) history of heart failure history of diabetes eGFR < 30 ml/min/1.73m2 standard contraindication to MRI, including history of severe allergy to gadolinium or Dotarem prior orchiectomy gender-affirming hormone therapy for greater than 5 months directly prior to enrollment current or past anti-platelet therapy or anti-coagulant therapy within the last 6 months •current or past statin therapy within the last 6 months concurrent enrollment in conflicting research study

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transgender women and non-binary individuals without HIV<br> | Other: Abdominal MR Imaging<br>* Imaging to evaluate visceral adipose tissue and hepatic lipid content<br>Other: Cardiac MRI/MRS<br>* Imaging to evaluate cardiac function and structure<br>Other: Oral Glucose Tolerance Testing<br>* Blood testing to evaluate changes in glucose and insulin in response to oral glucose load<br>Other: Whole Body, Lumbar Spine, and Hip DEXA Imaging<br>* Imaging to evaluate fat and lean body mass as well as bone mineral density<br>|
| Transgender women and non-binary individuals with HIV<br> | Other: Abdominal MR Imaging<br>* Imaging to evaluate visceral adipose tissue and hepatic lipid content<br>Other: Cardiac MRI/MRS<br>* Imaging to evaluate cardiac function and structure<br>Other: Oral Glucose Tolerance Testing<br>* Blood testing to evaluate changes in glucose and insulin in response to oral glucose load<br>Other: Whole Body, Lumbar Spine, and Hip DEXA Imaging<br>* Imaging to evaluate fat and lean body mass as well as bone mineral density<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visceral Adipose Tissue |  | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intramyocardial Triglyceride Content on Cardiac MRS |  | Baseline and 12 months | 
| Change in Diastolic Function on Cardiac MRI |  | Baseline and 12 months | 
| Change in Myocardial Fibrosis on Cardiac MRI |  | Baseline and 12 months | 
| Change in Glucose and Insulin Parameters on Oral Glucose Tolerance Testing |  | Baseline and 12 months | 
| Change in Bone Density |  | Baseline and 12 months | 
| Change in Hormonal Parameters |  | Baseline and 12 months | 
| Change in Coagulation Parameters |  | Baseline and 12 months | 
| Change in hepatic lipid content |  | Baseline and 12 months |