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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL147799-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institutes of Health (NIH) | NIH |
| American Heart Association | OTHER |
| Robert Wood Johnson Foundation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transgender women and non-binary individuals without HIV |
| ||
| Transgender women and non-binary individuals with HIV |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal MR Imaging | Other | Imaging to evaluate visceral adipose tissue and hepatic lipid content |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visceral Adipose Tissue | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intramyocardial Triglyceride Content on Cardiac MRS | Baseline and 12 months | |
| Change in Diastolic Function on Cardiac MRI | Baseline and 12 months | |
| Change in Myocardial Fibrosis on Cardiac MRI |
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Inclusion Criteria:
Exclusion Criteria:
Transgender Women
Transgender Women and Non-Binary Individuals
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| OTHER |
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| Cardiac MRI/MRS | Other | Imaging to evaluate cardiac function and structure |
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| Oral Glucose Tolerance Testing | Other | Blood testing to evaluate changes in glucose and insulin in response to oral glucose load |
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| Whole Body, Lumbar Spine, and Hip DEXA Imaging | Other | Imaging to evaluate fat and lean body mass as well as bone mineral density |
|
| Baseline and 12 months |
| Change in Glucose and Insulin Parameters on Oral Glucose Tolerance Testing | Baseline and 12 months |
| Change in Bone Density | Baseline and 12 months |
| Change in Hormonal Parameters | Baseline and 12 months |
| Change in Coagulation Parameters | Baseline and 12 months |
| Change in hepatic lipid content | Baseline and 12 months |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D002318 | Cardiovascular Diseases |
| D008659 | Metabolic Diseases |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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