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临床试验/NCT02550431
NCT02550431已完成不适用

Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Body composition as measured by Dual-energy X-ray absorptiometry (DEXA) in transgender youth compared to age- and BMI-matched controls of both sexes.

研究概览

简要总结

This study plans to learn more about puberty blockers and cross (testosterone and estradiol). There is not much known about how these medications affect hormone levels, heart health and overall general health in young transgender individuals.

详细描述

This study plans to learn more about puberty blockers and cross (testosterone and estradiol). There is not much known about how these medications affect hormone levels, heart health and overall general health in young transgender individuals.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
9 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Followed in Endocrinology Clinic or Adolescent Medicine Clinic at Children's Hospital Colorado
  • Between age 9 and 21 years (inclusive)
  • Identifies as transgender
  • Has been on pubertal blockade or cross-sex hormones for at least three months.

排除标准

  • Known diabetes
  • Presence of significant medical or psychiatric comorbidities
  • Using hormones not prescribed by a physician

结局指标

主要结局

Body composition as measured by Dual-energy X-ray absorptiometry (DEXA) in transgender youth compared to age- and BMI-matched controls of both sexes.

时间窗: at enrollment

Reproductive hormone concentrations in transgender youth on cross-sex hormones and/or puberty blockers and compared to age-, natal sex- and body mass index (BMI)-matched controls.

时间窗: at enrollment

Markers of cardiometabolic risk in transgender youth on cross-sex hormones and/or puberty blockers and compared to age-, natal sex- and BMI-matched controls

时间窗: at enrollment

Data on quality of life as measured by the Pediatric Quality of Life Inventory (PedsQL) compared to published norms

时间窗: at enrollment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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