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临床试验/NCT00372086
NCT00372086已完成4 期

The Addition of Rosiglitazone to Insulin in Adolescents With Type 1 Diabetes and Poor Glycaemic Control: a Randomized, Placebo Controlled Trial

The University of New South Wales2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2003年8月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
32
试验地点
2
主要终点
HbA1c

研究概览

简要总结

Type 1 Diabetes is the most common life-long disorder with onset in childhood. Patients need insulin injections, blood sugar monitoring several times each day, and adhere to a strict diet. Adequate control of blood glucose is essential to prevent long term kidney and eye complications that result in kidney failure and blindness. Adolescence is a time when diabetes is difficult to control, due in part to high growth hormone levels causing insulin resistance ( a state where the body does not respond as strongly to insulin). This study will test whether treatment with rosiglitazone (an oral medication used frequently in type 2 diabetes) will reduce the insulin resistance of adolescence and improve the control of type 1 diabetes during puberty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • T1DM duration > 1year
  • age 10-18years
  • HbA1c > 8%
  • puberty > Tanner stage 2 breast or testis >4ml

排除标准

  • known non-compliance
  • hypo unaware

结局指标

主要结局

HbA1c

次要结局

  • insulin dose
  • frequency of severe hypoglycaemia
  • insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp
  • weight
  • BMI-SDS
  • skin fold thickness
  • cholesterol
  • adiponectin

研究者

申办方类型
Other

研究点 (2)

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