NCT04596592招募中不适用
Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Brachial artery flow mediated dilation
研究概览
简要总结
To evaluate the effect of estradiol with or without a prior gonadotropin releasing hormone analogue on insulin sensitivity and vascular function in transgender females compared to cisgender controls.
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
- 13 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
- •Antipsychotic medication use
- •Type 1 or 2 diabetes (by medical history)
- •Polycystic ovarian syndrome (PCOS for cisgender females)
- •Hypertension (resting BP ≥ 140/90 mm/Hg)
- •Weight> 400 lbs
- •On oral progesterone medications (including oral progesterone or progestin, combined oral contraceptives or etonogestrel implant)
- •Pregnancy (for cisgender females)
结局指标
主要结局
Brachial artery flow mediated dilation
时间窗: Change from baseline to 12 months
Insulin sensitivity
时间窗: Change from baseline to 12 months
次要结局
- Cerebrovascular function(Change from baseline to 12 months)
- VO2 peak(Change from baseline to 12 months)
- Fat-free mass(Change from baseline to 12 months)
- Fat mass(Change from baseline to 12 months)
- Large artery stiffness(Change from baseline to 12 months)
研究者
研究点 (1)
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