Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis

This study is currently recruiting participants.
Verified April 2013 by University Hospital, Strasbourg, France
Sponsor:
Collaborator:
Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00476281
First received: May 18, 2007
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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 Intervention
Cystic Fibrosis
Diabetes
Procedure: Urinary collect
Procedure: Continuous Glucose Monitoring System (CGMS)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • nutritional and respiratory parameters [ Time Frame: five years ] [ Designated as safety issue: No ]
    descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.


Secondary Outcome Measures:
  • abnormal glucose tolerance [ Time Frame: five tears ] [ Designated as safety issue: No ]
    assess the prevalence of abnormal glucose tolerance.


Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
abnormal glucose tolerance
abnormal glucose tolerance
Procedure: Urinary collect Procedure: Continuous Glucose Monitoring System (CGMS)

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476281

Contacts
Contact: Laurence KESSLER, MD 33 3 88 11 65 95 laurence.kessler@chru-strasbourg.fr

Locations
France
Centre Robert Debré - CHU Angers Not yet recruiting
Angers, France
Contact: GINIES Jean-Louis, MD    02 41 35 49 87    jlginies@chu-angers.fr   
Contact: DUBOIS Séverine, MD       SeDubois@chu-angers.fr   
Hôpital Laennec - CHU de Nantes Not yet recruiting
Nantes, France
Contact: HALOUN Alain, MD    02 40 16 52 35    alain.haloun@chu-nantes.fr   
Contact: CHAILLOUS Lucy, MD       lucy.chaillous@chu-nantes.fr   
Service de Pédiatrie A - CHU de Reims Not yet recruiting
Reims, France
Contact: ABELY Michel, MD    03 26 78 70 07    mabely@chu-reims.fr   
Contact: RAVONINJATOVO Bruno, MD       bravoninjatovo@chu-reims.fr   
CRCM Centre de Perharidy Not yet recruiting
Roscoff, France, 29684
Contact: RAULT Gilles, MD    02 98 29 39 39    gilles.rault@perharidy.fr   
Contact: RAMEL Sophie, MD    02 98 29 39 39    sophie.ramel@perharidy.fr   
Service de Pédiatrie II Recruiting
Strasbourg, France, 67098
Contact: Laurence WEISS, MD    33 3 88 12 83 31    laurence.weiss@chru-strasbourg.fr   
Principal Investigator: Laurence WEISS, MD         
Service de Réanimation Médicale - Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Michel HASSELMANN, MD    33 3 88 11 50 41    michel.hasselmann@chru-strasbourg.fr   
Service d'Endocrinologie, Diabète et Maladies Métaboliques - Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Laurence KESSLER, MD    33 3 88 11 65 95    laurence.kessler@chru-strasbourg.fr   
Principal Investigator: Laurence KESSLER, MD         
Sub-Investigator: François MOREAU, MD         
Service de Pneumologie - Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Romain KESSLER, MD    33 3 88 12 78 37    romain.kessler@chru-strasbourg.fr   
Principal Investigator: Romain KESSLER, MD         
Sub-Investigator: Vincent ROSNER, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
Investigators
Study Director: Laurence KESSLER, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00476281     History of Changes
Other Study ID Numbers: 3887
Study First Received: May 18, 2007
Last Updated: April 23, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on April 17, 2014