Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
Primary Purpose
Cystic Fibrosis, Diabetes
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Urinary collect
Continuous Glucose Monitoring System (CGMS)
Sponsored by
About this trial
This is an interventional basic science trial for Cystic Fibrosis
Eligibility 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
- patient treated with the combination lumacaftor and ivacaftor
Sites / Locations
- Centre Robert Debré - CHU Angers
- Service d'Endocrinologie et Métabolisme - CHRU de Lille
- Hôpital Laennec - CHU de Nantes
- Service de Pédiatrie A - CHU de Reims
- CRCM Centre de Perharidy
- Service d'Endocrinologie, Diabète et Maladies Métaboliques - Hôpital Civil
- Service de Réanimation Médicale - Hôpital Civil
- Service de Pneumologie - Hôpital de Hautepierre
- Service de Pédiatrie II
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
abnormal glucose tolerance
Arm Description
abnormal glucose tolerance
Outcomes
Primary Outcome Measures
nutritional and respiratory parameters
descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.
Secondary Outcome Measures
abnormal glucose tolerance
assess the prevalence of abnormal glucose tolerance.
Full Information
NCT ID
NCT00476281
First Posted
May 18, 2007
Last Updated
April 24, 2020
Sponsor
University Hospital, Strasbourg, France
Collaborators
Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
1. Study Identification
Unique Protocol Identification Number
NCT00476281
Brief Title
Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
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 Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
abnormal glucose tolerance
Arm Type
Other
Arm Description
abnormal glucose tolerance
Intervention Type
Procedure
Intervention Name(s)
Urinary collect
Intervention Type
Procedure
Intervention Name(s)
Continuous Glucose Monitoring System (CGMS)
Primary Outcome Measure Information:
Title
nutritional and respiratory parameters
Description
descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.
Time Frame
five years
Secondary Outcome Measure Information:
Title
abnormal glucose tolerance
Description
assess the prevalence of abnormal glucose tolerance.
Time Frame
five tears
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
patient treated with the combination lumacaftor and ivacaftor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence KESSLER, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Study Director
Facility Information:
Facility Name
Centre Robert Debré - CHU Angers
City
Angers
Country
France
Facility Name
Service d'Endocrinologie et Métabolisme - CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Laennec - CHU de Nantes
City
Nantes
Country
France
Facility Name
Service de Pédiatrie A - CHU de Reims
City
Reims
Country
France
Facility Name
CRCM Centre de Perharidy
City
Roscoff
ZIP/Postal Code
29684
Country
France
Facility Name
Service d'Endocrinologie, Diabète et Maladies Métaboliques - Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Service de Réanimation Médicale - Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Service de Pneumologie - Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Service de Pédiatrie II
City
Strasbourg
ZIP/Postal Code
67098
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
24359972
Citation
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.
Results Reference
derived
Learn more about this trial
Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
We'll reach out to this number within 24 hrs