Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis
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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 |
- 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.
- 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 |
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| Contact: Laurence KESSLER, MD | 33 3 88 11 65 95 | laurence.kessler@chru-strasbourg.fr |
| 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 | |
| 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 May 23, 2013