ACTRN12611000068965进行中（未招募）2 期
Randomised controlled trial to determine whether once-daily insulin detemir slows decline in weight and lung function in patients with cystic fibrosis and early insulin deficiency
Sydney Children's Hospital0 个研究点目标入组 95 人开始时间: 2011年1月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 5 Years 至 19 Years（—）
- 性别
- All
入选标准
- •(1) Patients with Cystic Fibrosis aged >5 yrs attending Sydney Children’s Hospital (SCH), Children’s Hospital Westmead (CHW), John Hunter Children’s Hospital (JHCH), Lady Cilento Children's Hospital Brisbane (LCCB), or Women's and Children's Hospital Adelaide (WCHA).
- •(2) Cystic Fibrosis Insulin Deficiency Stage 1 or 2 (defined as peak blood glucose >=8.2 and 120-minute blood glucose <11.1mmol/l on OGTT performed within the last 6 months, when respiratory function stable, as judged by the treating respiratory team.
排除标准
- •(1) Diabetes, defined as 120-minute blood glucose on OGTT >=11.1mmol/L or fasting blood glucose >= 7mmol/L. Such patients will be offered insulin treatment as standard clinical care.
- •(2) Unstable respiratory disease (hospital admission for treatment of respiratory exacerbation within the last month)
- •(3) Current treatment with systemic glucocorticoids or treatment with systemic glucocorticoids of more than 1 month duration, within the last 12 months.
- •(4) Current treatment with fluoroquinolone antibiotics.
研究者
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