Clinical Trials Directory

Trials / Completed

CompletedNCT02569229

Glucose Tolerance in Children With Cystic Fibrosis

Glucose Tolerance and Its Clinical Impact in Children and Adolescents With Cystic Fibrosis

Status
Completed
Phase
Study type
Observational
Enrollment
14 (actual)
Sponsor
Christoph Saner · Academic / Other
Sex
All
Age
10 Years – 20 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERDiagnostics for glucose tolerance with 3 different methods.1. A 7-day course of subcutaneous continuous glucose monitoring system (CGMS). 2. An oral glucose tolerance test done within the 7 day period of CGMS. 3. Optionally a intravenous glucose tolerance test done within the 7 day period of CGMS.

Timeline

Start date
2015-06-01
Primary completion
2016-11-18
Completion
2016-11-18
First posted
2015-10-06
Last updated
2022-11-21

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT02569229. Inclusion in this directory is not an endorsement.