Effects of Gender-Affirming Hormone Therapy Among Transgender Women

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; HIV/AIDS; Transgender Women; Coagulopathy; Metabolic Disease
• Intervention / Treatment: Other: Abdominal MR Imaging; Other: Cardiac MRI/MRS; Other: Oral Glucose Tolerance Testing; Other: Whole Body, Lumbar Spine, and Hip DEXA Imaging

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Transgender Women and Non-Binary Individuals

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH); American Heart Association; Robert Wood Johnson Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Metabolic Diseases
• Other Study ID Numbers: 2019P001962; 1K23HL147799-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No