NCT04066283招募中不适用
Novel Evaluations of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women Compared to Age Group-Matched Cisgender Adults
适应症
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)
研究概览
简要总结
This study will examine markers of vascular endothelial function (vascular health) and metabolic profiles in younger versus older transgender women (people who were assigned male at birth but whose gender identity is female). Data will also be compared to those from cisgender women and men.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-40 years old or 50-75 years old
- •Identify as a transgender woman
- •Have taken estradiol and spironolactone for at least one year
- •Currently taking oral or transdermal estradiol
排除标准
- •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
- •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)
时间窗: Baseline
Brachial artery flow-mediated dilation (FMD), as measured by ultrasound.
次要结局
- Plasma lipid concentrations: total cholesterol(Baseline)
- Insulin sensitivity(Baseline)
- Whole body composition: Percent Lean Mass(Baseline)
- Evaluation of carotid artery compliance(Baseline)
- Evaluation of oxidant burden: oxidized LDL(Baseline)
- Evaluation of vascular endothelial cell inflammation: NFkB(Baseline)
- Evaluation of carotid artery beta stiffness index(Baseline)
- Weight changes(Baseline)
- Depression symptoms(Baseline)
- Carotid artery intimal-medial thickness(Baseline)
- Evaluation of vascular endothelial cell inflammation: IL-6(Baseline)
- Evaluation of vascular endothelial cell inflammation: CRP(Baseline)
- Blood pressure(Baseline)
- Evaluation of oxidant burden: nitrotyrosine(Baseline)
- Evaluation of vascular endothelial cell inflammation: MCP-1(Baseline)
- Plasma lipid concentrations: triglycerides(Baseline)
- Whole body composition: Percent Fat Mass(Baseline)
- Regional body composition: Percent Lean Mass(Baseline)
- D-Dimer(Baseline)
- Energy intake(3 days)
- Regional body composition: Percent Fat Mass(Baseline)
- Appetite ratings(Baseline)
- Appetite-related peptides(Baseline)
- Alcohol use(Baseline)
- Physical activity monitoring(7 days)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender MenTransgenderGender IdentityVascular StiffnessVascular InflammationBlood PressureLipid DisorderAppetitive BehaviorNCT04237467University of Colorado, Denver30
已完成
不适用
Circulating Endothelial Compartment During Normal and Pathological AgingHealthyNCT01038700Assistance Publique - Hôpitaux de Paris84
招募中
Unknown
Evaluation of association of vascular aging, chronic inflammation and degenerative brain diseaseMental and behavioural disordersKCT0008806Gachon University Gil Medical Center350
已完成
不适用
Evaluation of novel marker for ageing and metabolic disorders in human blood by metabolomic analysisageing, diabetisJPRN-UMIN000005239kyoto univ. hospital40
已完成
不适用
The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal WomenEndothelial DysfunctionNCT02256540University of Colorado, Denver25