NCT04128488

Effects of Gender-Affirming Hormone Therapy Among Transgender Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Male
• Age: 16 Years – 99 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-01
• Primary completion: 2024-03-28
• Completion: 2024-03-28
• First posted: 2019-10-16
• Last updated: 2025-05-18

Locations

1 site across 1 country: United States