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Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
This study is currently recruiting participants.
Verified by University Hospital, Strasbourg, France, January 2009
Sponsors and Collaborators: University Hospital, Strasbourg, France
Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
Information provided by: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00476281
  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)

Genetics Home Reference related topics: cystic fibrosis
MedlinePlus related topics: Cystic Fibrosis Diabetes
Drug Information available for: Dextrose
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Evaluation of Nutritional, Metabolic and Respiratory Status in Young Adult Patients With Cystic Fibrosis

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

Estimated Enrollment: 100
Study Start Date: April 2008
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient ≥ 12 years of age
  • Patient with cystic fibrosis
  • Patient without diabetes already known
  • Glycemia with jeun < 1.26g/l

Exclusion Criteria:

  • Pregnancy
  • Breast feeding
  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
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 Réanimation Médicale - Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Michel HASSELMANN, MD     33 3 88 11 50 41     michel.hasselmann@chru-strasbourg.fr    
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            
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            
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

Study ID Numbers: 3887
Study First Received: May 18, 2007
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00476281  
Health Authority: France: Ministry of Health

Study placed in the following topic categories:
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis
Lung Diseases
Diabetes Mellitus
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009