Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Nutritional status evaluated as variations of Z score of BMI
研究概览
简要总结
The purpose of this study is to evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.
详细描述
Diabetes mellitus may often complicate the cystic fibrosis course, and it is usually preceded by a condition defined as glucose intolerance, during which a significant decay of patient's general conditions is observed. A slow release insulin (glargine) has become available in the market for diabetic patients: its characteristics allow for a single daily dose, and no need of repeated daily monitoring of glycemia.
In this randomized controlled clinical trial we evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.
Eligible patients who will accept to participate to this study will be randomly allocated in the group who will or will not receive glargine as additional supportive therapy. Patients will in any case continue the CF therapy prescribed by their treating physicians and their usual diet. All the patients will be evaluated every three months to assess their nutritional, pulmonary and glycometabolic status. The follow-up will continue until the 18th month after the study entry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ascertained diagnosis of CF
- •Age ≥ 10 years
- •Glucide intolerance: 2 pathologic OGTT ( at 120' glucose value: >140 mg% and <200 mg%) at 2-6 months' interval between each other
- •At least one of the following conditions:
- •BMI (body mass index) < 10th centile for age and sex (according to Rolland Cachera 1991)
- •Loss of one BMI centile class for age and sex in the last year (according to Rolland Cachera 1991)
- •FEV1 ≤ 80% of predicted
- •FEV1 decrease ≥ 10% in the last year
排除标准
- •Specific contraindications for the use of glargine
研究组 & 干预措施
1
Insulin yes
干预措施: Insulin (Drug)
结局指标
主要结局
Nutritional status evaluated as variations of Z score of BMI
时间窗: At recruitment time and at +3, +6, +9, +12, +15, +18 months
次要结局
- Glucose tolerance improvement evaluated as improvement of glycometabolic parameter (glycosylated Hb)(At time recruitment and +3,+6,+9+12+15+18 months)