Effects of Gender-Affirming Hormone Therapy Among Transgender Women

Mass General Brigham

Status: Completed

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

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04128488

2019P001962

1K23HL147799-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: Male

Ages: 16 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

33 participants in 2 patient groups

Transgender women and non-binary individuals without HIV

Treatment:

Other: Whole Body, Lumbar Spine, and Hip DEXA Imaging

Other: Oral Glucose Tolerance Testing

Other: Abdominal MR Imaging

Other: Cardiac MRI/MRS

Transgender women and non-binary individuals with HIV

Treatment:

Other: Whole Body, Lumbar Spine, and Hip DEXA Imaging

Other: Oral Glucose Tolerance Testing

Other: Abdominal MR Imaging

Other: Cardiac MRI/MRS