Effects of Gender-Affirming Hormone Therapy Among Transgender Women

NCT04128488 | Completed

• 2 other identifiers: 2019P0019621K23HL147799-01
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Visceral Adipose Tissue

  Baseline and 12 months

Secondary Outcomes (8)

• 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

Study Arms (2)

Transgender women and non-binary individuals without HIV

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

Transgender women and non-binary individuals with HIV

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

Interventions

Abdominal MR Imaging OTHER

Imaging to evaluate visceral adipose tissue and hepatic lipid content

Transgender women and non-binary individuals with HIV; Transgender women and non-binary individuals without HIV

Cardiac MRI/MRS OTHER

Imaging to evaluate cardiac function and structure

Transgender women and non-binary individuals with HIV; Transgender women and non-binary individuals without HIV

Oral Glucose Tolerance Testing OTHER

Blood testing to evaluate changes in glucose and insulin in response to oral glucose load

Transgender women and non-binary individuals with HIV; Transgender women and non-binary individuals without HIV

Whole Body, Lumbar Spine, and Hip DEXA Imaging OTHER

Imaging to evaluate fat and lean body mass as well as bone mineral density

Transgender women and non-binary individuals with HIV; Transgender women and non-binary individuals without HIV

Eligibility Criteria

• Age: 16 Years - 99 Years
• Gender Eligibility Details: Transgender Women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Transgender Women and Non-Binary Individuals

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Talathi R, Juhasz V, Delgado M, Quinaglia T, Ghamari A, Wang M, Alhallak I, Stinebaugh S, Campbell S, Stockman SL, Ozturk MA, Ahmadi SM, Looby SE, Lee H, Poteat TC, Szczepaniak LS, Zanni MV, Neilan TG, Toribio M. Visceral adipose tissue and liver fat on 17-beta estradiol-dominant gender-affirming hormone therapy: A US-based cohort. J Clin Endocrinol Metab. 2025 Dec 12:dgaf665. doi: 10.1210/clinem/dgaf665. Online ahead of print.

  PMID: 41383103 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cardiovascular Diseases; Metabolic Diseases; Hemostatic Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: November 1, 2019
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)