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