Clinical trial NCT02569229: Glucose Tolerance in Children With Cystic Fibrosis
Official title: Glucose Tolerance and Its Clinical Impact in Children and Adolescents With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glucose Intolerance
Cystic Fibrosis
Keywords: children
cystic fibrosis
glucose intolerance
continuous glucose measurement
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
First posted: 2015-10-06
Enrollment: 14
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with genetically determined cystic fibrosis.

Brief summary: The aim is to describe the association of glucose tolerance measured with three different tools (continuous glucose measurement system - CGMS, oral glucose tolerance testing - OGTT and optional intravenous glucose tolerance testing -IVGTT) with parameters out of lung function and anthropometric parameters in patients with cystic fibrosis.

Detailed description: Patients with cystic fibrosis (CF) with progressing disease are developing a glucose tolerance which resembles the metabolic state of a diabetic patient because of increasing impairment of endocrine pancreatic function. The prevalence of this diabetic metabolic state is increasing with age, reaching around 20% at the age of 20 years.

Over the last decade, research has already highlighted the negative influence of cystic fibrosis related diabetes (CFRD) on morbidity and mortality after the diagnosis of this condition.

As the deterioration in nutritional status and lung function can already be noticed 2-6 years before the onset of CFRD, the importance of early diagnosis in glucose abnormalities and its treatment therefore is crucial.

The currently used method to evaluate altered glucose metabolism in patients with CF is an annual oral glucose tolerance test (OGTT) with the glucose value after 120 min after oral ingestion of glucose-fluid as reference. This method may detect CFRD much later than we see deterioration of lung function and weight loss. This deterioration and the mortality in CF is related to CFRD.

An alternative diagnostic tool that has gained increasing attention and that is already routinely used in pediatric patients with diabetes mellitus type I is the continuous glucose monitoring system (CGMS) which was shown to be much more sensitive in detecting glucose abnormalities. To assess pancreatic endocrine dysfunction - the pathophysiologic cause for glucose intolerance - intravenous glucose tolerance testing (IVGTT) is the gold standard.

The investigator's aim is to describe the association of glucose tolerance measured with three different tools/assessment procedures (CGMS, OGTT and optional IVGTT) with lung function and anthropometric parameters.

Eligibility criteria: Inclusion Criteria:

* Patients with confirmed cystic fibrosis aged between 10-20 years, under medical treatment at the University Children's Hospital Basel UKBB and at the University Children's Hospital, Inselspital Bern

Exclusion Criteria:

* Patients being under medical treatment with systemically administered glucocorticoid drugs or intravenously administered antibiotic treatment within 6 weeks before glucose tolerance testing.
* Patients with acute pulmonary exacerbation, defined by a pediatric pneumologist

Primary outcomes:
measure: % time spent above 8mmol/l, the area under the curve and the mean glucose value (in mmol/l)
timeFrame: Beginning at day 1, lasting 7 days
measure: The glucose values given in mmol/l after 30', 60', 90' and 120 minutes during OGTT.
timeFrame: Within the 7 day course of CGMS
measure: First phase insulin secretion and second phase insulin secretion out of IVGTT (intravenous glucose tolerance test).
timeFrame: Within the 7 day course of CGMS
measure: FEV1% (forced expiratory volume at one second) out of the lung function testing
timeFrame: Within 3 months of the 7 day course of CGMS
measure: Lung clearance index
timeFrame: Within 3 months of the 7 day course of CGMS
measure: BMI-SDS (standard deviation score).
timeFrame: At day 1 of the CGMS course
measure: HbA1c
timeFrame: Within the 7 day course of CGMS
Secondary outcomes:
measure: Comparing the performance between CGMS and OGTT related to clinical parameters.
timeFrame: 7 days
Other outcomes:
measure: Characterising glucose profiles over 24 hours
timeFrame: 7 days
Locations:
city: Basel
country: Switzerland
facility: University childrens hospital Basel, UKBB
Study officials:
affiliation: University childrens Hospital, UKBB, Basel Switzerland
name: Christoph Saner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University childrens Hospital, UKBB, Basel Switzerland
name: Urs Zumsteg, Prof
role: STUDY_DIRECTOR
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