Clinical trial NCT04128488: Effects of Gender-Affirming Hormone Therapy Among Transgender Women
Official title: Effects of Gender-Affirming Hormone Therapy Among Transgender Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transgender Women
HIV/AIDS
Cardiovascular Diseases
Metabolic Disease
Coagulopathy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institutes of Health (NIH)
name: American Heart Association
name: Robert Wood Johnson Foundation
First posted: 2019-10-16
Enrollment: 33
Sex: MALE
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Transgender Women and Non-Binary Individuals

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.


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

Primary outcomes:
measure: Change in Visceral Adipose Tissue
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Intramyocardial Triglyceride Content on Cardiac MRS
timeFrame: Baseline and 12 months
measure: Change in Diastolic Function on Cardiac MRI
timeFrame: Baseline and 12 months
measure: Change in Myocardial Fibrosis on Cardiac MRI
timeFrame: Baseline and 12 months
measure: Change in Glucose and Insulin Parameters on Oral Glucose Tolerance Testing
timeFrame: Baseline and 12 months
measure: Change in Bone Density
timeFrame: Baseline and 12 months
measure: Change in Hormonal Parameters
timeFrame: Baseline and 12 months
measure: Change in Coagulation Parameters
timeFrame: Baseline and 12 months
measure: Change in hepatic lipid content
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: