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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00476281
Enrollment
114
Registered
2007-05-21
Start date
2008-04-30
Completion date
2020-01-31
Last updated
2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Diabetes

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.

Interventions

PROCEDUREUrinary collect

Sponsors

Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine
CollaboratorOTHER
University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
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 * patient treated with the combination lumacaftor and ivacaftor

Design outcomes

Primary

MeasureTime frameDescription
nutritional and respiratory parametersfive yearsdescriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.

Secondary

MeasureTime frameDescription
abnormal glucose tolerancefive tearsassess the prevalence of abnormal glucose tolerance.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026