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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.
Age
16 - 99 years
Sex
MALE
Healthy Volunteers
Yes
Massachusetts General Hospital
Boston, Massachusetts, United States
Start Date
November 1, 2019
Primary Completion Date
March 28, 2024
Completion Date
March 28, 2024
Last Updated
May 18, 2025
33
ACTUAL participants
Abdominal MR Imaging
OTHER
Cardiac MRI/MRS
OTHER
Oral Glucose Tolerance Testing
OTHER
Whole Body, Lumbar Spine, and Hip DEXA Imaging
OTHER
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT06909773
NCT06505109
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06189313