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Effects of Gender-Affirming Hormone Therapy Among Transgender Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04128488
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : October 17, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Mabel Toribio, Massachusetts General Hospital

Brief Summary:
In this study, investigators plan to evaluate the cardiometabolic effects of initiating gender-affirming hormone therapy among transgender women with HIV. As part of this study, participants will undergo cardiovascular and metabolic phenotyping before 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.

Condition or disease Intervention/treatment
Transgender Women HIV/AIDS Cardiovascular Diseases Metabolic Disease Coagulopathy Other: Abdominal MR Imaging Other: Cardiac MRI/MRS Other: Oral Glucose Tolerance Testing Other: Whole Body, Lumbar Spine, and Hip DEXA Imaging

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Gender-Affirming Hormone Therapy Among Transgender Women
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Abdominal MR Imaging
    Imaging to visceral adipose tissue
  • 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


Primary Outcome Measures :
  1. Change in Visceral Adipose Tissue [ Time Frame: Baseline and 12 months ]

Secondary Outcome Measures :
  1. Change in Intramyocardial Triglyceride Content on Cardiac MRS [ Time Frame: Baseline and 12 months ]
  2. Change in Diastolic Function on Cardiac MRI [ Time Frame: Baseline and 12 months ]
  3. Change in Myocardial Fibrosis on Cardiac MRI [ Time Frame: Baseline and 12 months ]
  4. Change in Glucose and Insulin Parameters on Oral Glucose Tolerance Testing [ Time Frame: Baseline and 12 months ]
  5. Change in Bone Density [ Time Frame: Baseline and 12 months ]
  6. Change in Hormonal Parameters [ Time Frame: Baseline and 12 months ]
  7. Change in Coagulation Parameters [ Time Frame: Baseline and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Transgender Women
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Transgender Women with HIV
Criteria

Inclusion Criteria:

  • transgender women
  • HIV positive
  • age ≥18
  • on ART therapy for ≥3 months
  • initiation of testosterone suppression with spironolactone and estrogen therapy with oral 17-β estradiol by medical provider

Exclusion Criteria:

  • 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
  • current or past gender-affirming hormone therapy within the last 12 months
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128488


Contacts
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Contact: Mabel Toribio 617-724-2826 mptoribio@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mabel Toribio    617-724-2826    mptoribio@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

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Responsible Party: Mabel Toribio, Instructor in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04128488    
Other Study ID Numbers: 2019P001962
1K23HL147799-01 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Diseases
Cardiovascular Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs