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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Diabetes Procedure: Urinary collect Procedure: Continuous Glucose Monitoring System (CGMS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis
Study Start Date : April 2008
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Dextrose

Arm Intervention/treatment
abnormal glucose tolerance
abnormal glucose tolerance
Procedure: Urinary collect
Procedure: Continuous Glucose Monitoring System (CGMS)

Primary Outcome Measures :
  1. nutritional and respiratory parameters [ Time Frame: five years ]
    descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.

Secondary Outcome Measures :
  1. abnormal glucose tolerance [ Time Frame: five tears ]
    assess the prevalence of abnormal glucose tolerance.

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00476281

Contact: Laurence KESSLER, MD 33 3 88 11 65 95

Centre Robert Debré - CHU Angers Recruiting
Angers, France
Contact: GINIES Jean-Louis, MD    02 41 35 49 87   
Contact: DUBOIS Séverine, MD   
Service d'Endocrinologie et Métabolisme - CHRU de Lille Recruiting
Lille, France, 59037
Contact: Marie-christine VANTYGHEM-HAUDIQUET, MD   
Hôpital Laennec - CHU de Nantes Recruiting
Nantes, France
Contact: HALOUN Alain, MD    02 40 16 52 35   
Contact: CHAILLOUS Lucy, MD   
Service de Pédiatrie A - CHU de Reims Recruiting
Reims, France
Contact: ABELY Michel, MD    03 26 78 70 07   
Contact: RAVONINJATOVO Bruno, MD   
CRCM Centre de Perharidy Recruiting
Roscoff, France, 29684
Contact: RAULT Gilles, MD    02 98 29 39 39   
Contact: RAMEL Sophie, MD    02 98 29 39 39   
Service d'Endocrinologie, Diabète et Maladies Métaboliques - Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Laurence KESSLER, MD    33 3 88 11 65 95   
Principal Investigator: Laurence KESSLER, MD         
Sub-Investigator: François MOREAU, MD         
Service de Réanimation Médicale - Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Michel HASSELMANN, MD    33 3 88 11 50 41   
Service de Pneumologie - Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Romain KESSLER, MD    33 3 88 12 78 37   
Principal Investigator: Romain KESSLER, MD         
Sub-Investigator: Vincent ROSNER, MD         
Service de Pédiatrie II Recruiting
Strasbourg, France, 67098
Contact: Laurence WEISS, MD    33 3 88 12 83 31   
Principal Investigator: Laurence WEISS, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
Study Director: Laurence KESSLER, MD Hôpitaux Universitaires de Strasbourg

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Strasbourg, France Identifier: NCT00476281     History of Changes
Other Study ID Numbers: 3887
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases