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临床试验/NCT00476281
NCT00476281已完成不适用

Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis

University Hospital, Strasbourg, France15 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2008年4月1日最近更新:
适应症

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

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)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (15)

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