The Effects of Orchiectomy and Age on Vascular and Metabolic Health in Older Versus Younger Transgender Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of endothelial function (flow-mediated dilation (FMD) at 1 Month
研究概览
简要总结
This study plans to learn more about differences in heart disease risk after gender-affirming orchiectomy (i.e., testes removal) in older transgender (trans) women compared to younger trans women.
详细描述
The global aim of this study is to characterize cardiometabolic risk (measured by vascular, metabolic and biochemical factors-which have not been extensively studied prospectively) in trans women before and after orchiectomy. Trans women appear to be at greater risk for cardiovascular disease (CVD) and blood clots compared to non-trans adults. The effect of orchiectomy on CVD risk among trans women is unknown, but orchiectomy may change blood vessel function and metabolic health. The investigators will examine blood vessel function and metabolic profiles of trans women before and at several timepoints after orchiectomy to identify age-related differences in CVD risk factors. This knowledge may lead to new approaches to prevent CVD in trans women as well as all people regardless of gender identity.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years and older
- •Identify as a transgender woman
- •Have taken estradiol and spironolactone for at least one year
- •Currently taking oral or transdermal or injectable estradiol
- •Have not yet undergone but desire orchiectomy
排除标准
- •Under 18 years of age
- •Don't identify as a transgender woman
- •Not currently taking estradiol or spironolactone
- •Have been on estradiol and spironolactone for less than one year
- •History of orchiectomy
- •Not deemed a candidate for orchiectomy
- •Current tobacco smoker
- •Current illicit drug use
- •History of prior or active estrogen-dependent neoplasms
- •Acute liver or gallbladder disease
- •Venous thromboembolism
- •Hypertriglyceridemia >500 mg/dL
- •Fasted plasma glucose >7.0 mmol/L or previously treated diabetes
- •Resting blood pressure >140/90 mmHg
结局指标
主要结局
Evaluation of endothelial function (flow-mediated dilation (FMD) at 1 Month
时间窗: 1 month
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Evaluation of endothelial function (flow-mediated dilation (FMD) at Baseline
时间窗: Baseline
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Evaluation of endothelial function (flow-mediated dilation (FMD) at 6 Months
时间窗: 6 month
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
Evaluation of endothelial function (flow-mediated dilation (FMD) at 12 Months
时间窗: 12 month
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
次要结局
- Appetite ratings(Baseline, 1 mo., 6 mo., 12 mo.)
- Whole body composition: Percent Fat Mass(Baseline, 6 mo., 12 mo.)
- Regional body composition: Percent Fat Mass(Baseline, 6 mo., 12 mo.)
- Weight changes(Baseline, 1 mo., 6 mo., 12 mo.)
- Evaluation of vascular endothelial cell inflammation: MCP-1(Baseline, 1 mo., 6 mo., 12 mo.)
- Plasma lipid concentrations: triglycerides(Baseline, 1 mo., 6 mo., 12 mo.)
- Whole body composition: Percent Lean Mass(Baseline, 6 mo., 12 mo.)
- Bone density(Baseline, 12 mo.)
- Alcohol use(Baseline, 1 mo., 6 mo., 12 mo.)
- Sex hormone concentrations(Baseline, 1 mo., 6 mo., 12 mo.)
- Evaluation of carotid artery compliance(Baseline, 1 mo., 6 mo., 12 mo.)
- Evaluation of oxidant burden: oxidized LDL(Baseline, 1 mo., 6 mo., 12 mo.)
- Appetite-related peptides(Baseline, 1 mo., 6 mo., 12 mo.)
- Energy intake(3 days at baseline, 1 mo., 6 mo., 12 mo.)
- Carotid artery intimal-medial thickness(Baseline, 1 mo., 6 mo., 12 mo.)
- Evaluation of oxidant burden: nitrotyrosine(Baseline, 1 mo., 6 mo., 12 mo.)
- Evaluation of vascular endothelial cell inflammation: nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB)(Baseline, 1 mo., 6 mo., 12 mo.)
- Evaluation of vascular endothelial cell inflammation: CRP(Baseline, 1 mo., 6 mo., 12 mo.)
- Blood pressure(Baseline, 1 mo., 6 mo., 12 mo.)
- Plasma lipid concentrations: total cholesterol(Baseline, 1 mo., 6 mo., 12 mo.)
- Insulin sensitivity(Baseline, 1 mo., 6 mo., 12 mo.)
- Evaluation of carotid artery beta stiffness index(Baseline, 1 mo., 6 mo., 12 mo.)
- Evaluation of vascular endothelial cell inflammation: IL-6(Baseline, 1 mo., 6 mo., 12 mo.)
- Regional body composition: Percent Lean Mass(Baseline, 6 mo., 12 mo.)
- D-Dimer(Baseline, 1 mo., 6 mo., 12 mo.)
- Depression symptoms(Baseline, 1 mo., 6 mo., 12 mo.)
- Physical activity monitoring(7 days at baseline, 1 mo., 6 mo., 12 mo.)