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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04128488
Other study ID # 2019P001962
Secondary ID 1K23HL147799-01
Status Active, not recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date November 1, 2024

Study information

Verified date February 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 33
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 16 Years to 99 Years
Eligibility 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-ß estradiol, transdermal 17ß 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 Design


Intervention

Other:
Abdominal MR Imaging
Imaging to evaluate visceral adipose tissue and hepatic lipid content
Cardiac MRI/MRS
Imaging to evaluate cardiac function and structure
Oral Glucose Tolerance Testing
Blood testing to evaluate changes in glucose and insulin in response to oral glucose load
Whole Body, Lumbar Spine, and Hip DEXA Imaging
Imaging to evaluate fat and lean body mass as well as bone mineral density

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Visceral Adipose Tissue Baseline and 12 months
Secondary Change in Intramyocardial Triglyceride Content on Cardiac MRS Baseline and 12 months
Secondary Change in Diastolic Function on Cardiac MRI Baseline and 12 months
Secondary Change in Myocardial Fibrosis on Cardiac MRI Baseline and 12 months
Secondary Change in Glucose and Insulin Parameters on Oral Glucose Tolerance Testing Baseline and 12 months
Secondary Change in Bone Density Baseline and 12 months
Secondary Change in Hormonal Parameters Baseline and 12 months
Secondary Change in Coagulation Parameters Baseline and 12 months
Secondary Change in hepatic lipid content Baseline and 12 months
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