Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis

NCT00476281 | Completed

• 1 other identifier: 3887
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 9

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.

Conditions

Cystic Fibrosis; Diabetes

Outcome Measures

Primary Outcomes (1)

• nutritional and respiratory parameters

  descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.

  five years

Secondary Outcomes (1)

• abnormal glucose tolerance

  five tears

Study Arms (1)

abnormal glucose tolerance

OTHER

abnormal glucose tolerance

Procedure: Urinary collect; Procedure: Continuous Glucose Monitoring System (CGMS)

Interventions

Urinary collect PROCEDURE

abnormal glucose tolerance

Continuous Glucose Monitoring System (CGMS) PROCEDURE

abnormal glucose tolerance

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead
• Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine: collaborator

Study Sites (9)

Centre Robert Debré - CHU Angers

Angers, France

Location

Service d'Endocrinologie et Métabolisme - CHRU de Lille

Lille, 59037, France

Location

Hôpital Laennec - CHU de Nantes

Nantes, France

Location

Service de Pédiatrie A - CHU de Reims

Reims, France

Location

CRCM Centre de Perharidy

Roscoff, 29684, France

Location

Service d'Endocrinologie, Diabète et Maladies Métaboliques - Hôpital Civil

Strasbourg, 67091, France

Location

Service de Réanimation Médicale - Hôpital Civil

Strasbourg, 67091, France

Location

Service de Pneumologie - Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Service de Pédiatrie II

Strasbourg, 67098, France

Location

Related Publications (1)

• 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.

  PMID: 24359972 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Laurence KESSLER, MD

  Hôpitaux Universitaires de Strasbourg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 21, 2007
• Study Start: April 1, 2008
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-03

Locations

FR (9)