Cardiovascular Diseases, Coagulopathy, HIV/AIDS, Metabolic Disease, Transgender Women
Conditions
Brief summary
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.
Interventions
OTHERAbdominal MR Imaging
Imaging to evaluate visceral adipose tissue and hepatic lipid content
OTHERCardiac MRI/MRS
Imaging to evaluate cardiac function and structure
Blood testing to evaluate changes in glucose and insulin in response to oral glucose load
OTHERWhole Body, Lumbar Spine, and Hip DEXA Imaging
Imaging to evaluate fat and lean body mass as well as bone mineral density
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
American Heart Association
Robert Wood Johnson Foundation
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
16 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Visceral Adipose Tissue | Baseline and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 Intramyocardial Triglyceride Content on Cardiac MRS | 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 |
| Change in Bone Density | Baseline and 12 months |
Countries
United States
Outcome results
None listed