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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Cystic Fibrosis
• Intervention / Treatment: Procedure: Urinary collect; Procedure: Continuous Glucose Monitoring System (CGMS)

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Centre Robert Debré - CHU Angers
  • Lille, France, 59037
    • Service d'Endocrinologie et Métabolisme - CHRU de Lille
  • Nantes, France
    • Hopital Laennec - CHU de Nantes
  • Reims, France
    • Service de Pédiatrie A - CHU de Reims
  • Roscoff, France, 29684
    • CRCM Centre de Perharidy
  • Strasbourg, France, 67091
    • Service d'Endocrinologie, Diabète et Maladies Métaboliques - Hôpital Civil
  • Strasbourg, France, 67091
    • Service de Réanimation Médicale - Hôpital Civil
  • Strasbourg, France, 67098
    • Service de Pneumologie - Hôpital de Hautepierre
  • Strasbourg, France, 67098
    • Service de Pédiatrie II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: abnormal glucose tolerance	Procedure: Urinary collect; Procedure: Continuous Glucose Monitoring System (CGMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nutritional and respiratory parameters	descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.	five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
abnormal glucose tolerance	assess the prevalence of abnormal glucose tolerance.	five tears

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Collaborators: Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
• Investigators: Study Director: Laurence KESSLER, MD, Hôpitaux Universitaires de Strasbourg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: May 18, 2007
• First Submitted That Met QC Criteria: May 18, 2007
• First Posted (Estimate): May 21, 2007

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 3887