Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 15
- 主要终点
- nutritional and respiratory parameters
研究概览
简要总结
Diabetes is a important complication of cystic fibrosis (CF). The improved life expectancy of patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an increasing prevalence of cystic fibrosis-related diabetes (CFRD). CFRD is associated with accelerated pulmonary decline and increased mortality. Pulmonary effects are seen some years before the diagnosis of CFRD implying that impaired glucose tolerance may be very early detrimental. Insulin treatment is clearly indicated in patients with CFRD to control symptoms and reduce complications. However, at the state of impaired glucose tolerance or fasting hyperglycaemia, current screening methods are not suitable for the early management of hyperglycaemia.The recent introduction of the continuous glucose monitoring system (CGMS), which provides a continuous glucose profile, has revealed to be clinically relevant in the investigation of glucose excursions over a long period. This device, widely use in diabetic non cystic fibrosis patients, has been validated in non diabetic cystic fibrosis subjects. Previous studies of continuous glucose monitoring have been realized in CF patients with normal glucose tolerance and diabetes and compared with non CF controlThe aim of our study is to evaluate the glucose profile with continuous glucose monitoring the nutritional and respiratory status in cystic fibrosis subjects, according to their glucose tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 10 years and older with cystic fibrosis
- •not known diabetics with fasting blood glucose <1.26 g / l
- •outside periods of exacerbation and / or glucocorticoid therapy
- •affiliated to a social security scheme
- •having received the results of the mandatory medical examination
- •having signed an informed consent
排除标准
- •Patient transplanted lung and / or liver
- •Subject during participation in an interventional clinical trial
- •unable to give informed about the information
- •patient under judicial protection
- •patient under tutorship or curatorship
- •pregnancy
- •breastfeeding
- •patient treated with the combination lumacaftor and ivacaftor
结局指标
主要结局
nutritional and respiratory parameters
时间窗: five years
descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.
次要结局
- abnormal glucose tolerance(five tears)
