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临床试验/NCT02160717
NCT02160717已完成不适用

Beta-Cell Function in Young Turner Syndrome Patients

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年5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
120
试验地点
1
主要终点
Beta-Cell Function measured as Disposition Index

研究概览

简要总结

Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome have abnormalities in glucose metabolism which can lead to diabetes. The current screening guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood sugar once a year. The objective of this study is to determine if there are abnormalities in glucose metabolism and pancreatic function in young girls with Turner Syndrome. The study hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin) is more prevalent in girls with Turner Syndrome compared to healthy controls.

详细描述

The study will be conducted at Children's Hospital Medical Center, Cincinnati. The study will require 1 visit to the hospital where the subject will have an oral glucose tolerance test and a physical exam

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
6 Years 至 22 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Turner Syndrome confirmed by chromosomal testing
  • On standard therapy (growth hormone and or estrogen)

排除标准

  • Type 1 or Type 2 diabetes
  • Polycystic Ovarian Syndrome
  • Pregnancy
  • On any medications that alter blood sugar
  • Healthy Female Controls:
  • Inclusion Criteria:
  • Exclusion Criteria:
  • Type 1 or Type 2 diabetes
  • Polycystic Ovarian Syndrome
  • Pregnancy
  • On any medications that alter blood sugar

结局指标

主要结局

Beta-Cell Function measured as Disposition Index

时间窗: 1 day at screening

Disposition index will be calculated based on the results of the oral glucose tolerance test using minimal modeling (computer program)

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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