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Effects of Gender-Affirming Hormone Therapy Among Transgender Women

CompletedN/A

Sponsor: Massachusetts General Hospital

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

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

Countries: United States

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.

Eligibility overview

Sex: MALE

Age: 16 Years to 99 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Boston, Massachusetts, United States