Glucose Tolerance in Children With Cystic Fibrosis

NCT ID: NCT02569229

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-11-18

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.

Conditions

Glucose Intolerance; Cystic Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Diagnostics for glucose tolerance with 3 different methods.

Intervention Type: OTHER

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.

Interventions

Diagnostics 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

Christoph Saner

OTHER

Sponsor Role: lead

Responsible Party

Christoph Saner

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christoph Saner, MD

Role: PRINCIPAL_INVESTIGATOR

University childrens Hospital, UKBB, Basel Switzerland

Urs Zumsteg, Prof

Role: STUDY_DIRECTOR

University childrens Hospital, UKBB, Basel Switzerland

Locations

University childrens hospital Basel, UKBB

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

KEK BE: 102/15

Identifier Type: OTHER

Identifier Source: secondary_id

EKNZ 2015-143

Identifier Type: -

Identifier Source: org_study_id