GluTolCF: Glucose Tolerance in Children With Cystic Fibrosis

Sponsor

Christoph Saner (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02569229

Collaborator

University Hospital Inselspital, Berne (Other)

Enrollment

Location

420

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glucose Intolerance Cystic Fibrosis	Other: Diagnostics for glucose tolerance with 3 different methods.

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.

Study Design

Study Type:

Observational

Actual Enrollment :

14 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Jun 1, 2050

Arms and Interventions

Arm	Intervention/Treatment
Patients with Cystic Fibrosis 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).	Other: 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.

Arm

Intervention/Treatment

Patients with Cystic Fibrosis

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).

Other: 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Comparing the performance between CGMS and OGTT related to clinical parameters. [7 days]
The investigators compare the fit of a linear regression between the % time above 8mmol/l (out of CGMS) and the lung clearance index (LCI) with the fit of a linear regression of the 120min glucose value (out of OGTT) and the LCI. The same analysis will be performed comparing the fit of a regression between the % time above 8mmol/l (out of CGMS) and the FEV1% (out of lung function) with the fit of a linear regression of the 120min glucose value (out of OGTT) and the FEV1%. Finally, the same analysis will be performed comparing the fit of a linear regression using the % time above 8mmol/l (out of CGMS) and the BMI-SDS with the fit of a linear regression of the 120min glucose value (out of OGTT) and the BMI-SDS.

Other Outcome Measures

Characterising glucose profiles over 24 hours [7 days]
The investigators will describe computer-based modelling of the glucose curves obtained with the CGMS, aiming to describe inter-/ and intraindividual variability in the profiles.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University childrens hospital Basel, UKBB	Basel		Switzerland	4056

Sponsors and Collaborators

Christoph Saner
University Hospital Inselspital, Berne

Investigators

Principal Investigator: Christoph Saner, MD, University childrens Hospital, UKBB, Basel Switzerland
Study Director: Urs Zumsteg, Prof, University childrens Hospital, UKBB, Basel Switzerland