Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00476281
Recruitment Status : Recruiting
First Posted : May 21, 2007
Last Update Posted : April 11, 2016
Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

May 18, 2007
May 21, 2007
April 11, 2016
April 2008
October 2023   (Final data collection date for primary outcome measure)
nutritional and respiratory parameters [ Time Frame: five years ]
descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.
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Complete list of historical versions of study NCT00476281 on Archive Site
abnormal glucose tolerance [ Time Frame: five tears ]
assess the prevalence of abnormal glucose tolerance.
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Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis
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.
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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Cystic Fibrosis
  • Diabetes
  • Procedure: Urinary collect
  • Procedure: Continuous Glucose Monitoring System (CGMS)
abnormal glucose tolerance
abnormal glucose tolerance
  • Procedure: Urinary collect
  • Procedure: Continuous Glucose Monitoring System (CGMS)
Leclercq A, Gauthier B, Rosner V, Weiss L, Moreau F, Constantinescu AA, Kessler R, Kessler L. Early assessment of glucose abnormalities during continuous glucose monitoring associated with lung function impairment in cystic fibrosis patients. J Cyst Fibros. 2014 Jul;13(4):478-84. doi: 10.1016/j.jcf.2013.11.005. Epub 2013 Dec 17.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2023
October 2023   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
10 Years and older   (Child, Adult, Older Adult)
Contact: Laurence KESSLER, MD 33 3 88 11 65 95
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University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
Study Director: Laurence KESSLER, MD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP