Overview

This trial is active, not recruiting.

Conditions glucose intolerance, cystic fibrosis
Treatment diagnostics for glucose tolerance with 3 different methods.
Sponsor Christoph Saner
Collaborator University Hospital Inselspital, Berne
Start date June 2015
End date November 2016
Trial size 14 participants
Trial identifier NCT02569229, EKNZ 2015-143, KEK BE: 102/15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients between 10-20 years of age with genetically determined cystic fibrosis followed at the university children`s hospital Basel and university children`s hospital Kinderklinik Bern, Switzerland. All patients will get the diagnostics for glucose tolerance with 3 different methods (CGMS, OGTT and optionally IVGTT).
diagnostics for glucose tolerance with 3 different methods.
A 7-day course of subcutaneous continuous glucose monitoring system (CGMS). An oral glucose tolerance test done within the 7 day period of CGMS. Optionally a intravenous glucose tolerance test done within the 7 day period of CGMS.

Primary Outcomes

Measure
% time spent above 8mmol/l, the area under the curve and the mean glucose value (in mmol/l)
time frame: Beginning at day 1, lasting 7 days
The glucose values given in mmol/l after 30`, 60`, 90` and 120 minutes during OGTT.
time frame: Within the 7 day course of CGMS
First phase insulin secretion and second phase insulin secretion out of IVGTT (intravenous glucose tolerance test).
time frame: Within the 7 day course of CGMS
FEV1% (forced expiratory volume at one second) out of the lung function testing
time frame: Within 3 months of the 7 day course of CGMS
Lung clearance index
time frame: Within 3 months of the 7 day course of CGMS
BMI-SDS (standard deviation score).
time frame: At day 1 of the CGMS course
HbA1c
time frame: Within the 7 day course of CGMS

Secondary Outcomes

Measure
Comparing the performance between CGMS and OGTT related to clinical parameters.
time frame: 7 days

Eligibility Criteria

Male or female participants from 10 years up to 20 years old.

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

Additional Information

Official title Glucose Tolerance and Its Clinical Impact in Children and Adolescents With Cystic Fibrosis
Principal investigator Christoph Saner, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Hospital, Basel, Switzerland.