NCT04482374招募中不适用
Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health
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
- Change in insulin sensitivity
研究概览
简要总结
This observational study will evaluate the effect of puberty suppression on insulin sensitivity, metabolic rate and vascular health among transgender female youth at baseline and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched cisgender male 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
- 9 Years 至 14 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Identify as a transgender female or cisgender male
- •Age 9-14 years at the time of enrollment
- •Tanner Stage 2-3 baseline pubertal development
- •Plan to start gonadotropin releasing hormone analogue clinically in < 2 months (for transgender females only)
排除标准
- •Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
- •Type 1 or 2 diabetes (by medical history)
- •On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics)
- •Hypertension (resting BP ≥ 140/90 mm/Hg)
- •Weight > 400 lbs
- •On estrogen- or progesterone-containing medications at baseline
- •>3 hours of moderate-to-vigorous physical activity on the 3DPAR at the screening visit
结局指标
主要结局
Change in insulin sensitivity
时间窗: Baseline, 6 months
Insulin sensitivity assessed by the oral minimal model
次要结局
- Change in body composition (fat mass, fat-free mass)(Baseline, 6 months)
- Change in resting metabolic rate(Baseline, 6 months)
- Change in large elastic artery stiffness(Baseline, 6 months)
- Change in endothelial function(Baseline, 6 months)
- Change in cerebrovascular function(Baseline, 6 months)
研究者
研究点 (1)
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