Effects of Gender-Affirming Hormone Therapy Among Transgender Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Visceral Adipose Tissue
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •transgender women or non-binary individual
- •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-β estradiol, transdermal 17β estradiol, sublingual estradiol, intramuscular estradiol, or subcutaneous estradiol by medical provider
排除标准
- •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
结局指标
主要结局
Change in Visceral Adipose Tissue
时间窗: Baseline and 12 months
次要结局
- Change in Intramyocardial Triglyceride Content on Cardiac MRS(Baseline and 12 months)
- Change in Myocardial Fibrosis on Cardiac MRI(Baseline and 12 months)
- Change in Bone Density(Baseline and 12 months)
- Change in Coagulation Parameters(Baseline and 12 months)
- Change in Diastolic Function on Cardiac MRI(Baseline and 12 months)
- Change in Glucose and Insulin Parameters on Oral Glucose Tolerance Testing(Baseline and 12 months)
- Change in Hormonal Parameters(Baseline and 12 months)
- Change in hepatic lipid content(Baseline and 12 months)
研究者
Mabel Toribio
Assistant Professor
Massachusetts General Hospital