Effects of Gender-Affirming Hormone Therapy Among Transgender Women

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

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• American Heart Association

  collaborator OTHER

• Robert Wood Johnson Foundation

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Eligibility

Min Age

16 Years

Max Age

99 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-01

Primary Completion

2024-03-28

Completion

2024-03-28

Countries

• United States

Study Locations