Glucose Tolerance in Children With Cystic Fibrosis

NCT02569229 | Completed DMC

• 2 other identifiers: EKNZ 2015-143KEK BE: 102/15
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Intolerance; Cystic Fibrosis

Keywords

children; cystic fibrosis; glucose intolerance; continuous glucose measurement

Outcome Measures

Primary Outcomes (7)

• % time spent above 8mmol/l, the area under the curve and the mean glucose value (in mmol/l)

  These measurements will be gained out of the 7 day CGMS-course (continuous glucose monitoring system).

  Beginning at day 1, lasting 7 days

• The glucose values given in mmol/l after 30', 60', 90' and 120 minutes during OGTT.

  Standard oral glucose tolerance test.

  Within the 7 day course of CGMS

• First phase insulin secretion and second phase insulin secretion out of IVGTT (intravenous glucose tolerance test).

  Standard intravenous glucose tolerance test.

  Within the 7 day course of CGMS

• 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 Outcomes (1)

• Comparing the performance between CGMS and OGTT related to clinical parameters.

  7 days

Other Outcomes (1)

• Characterising glucose profiles over 24 hours

  7 days

Study Arms (1)

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.

Interventions

Diagnostics for glucose tolerance with 3 different methods. 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.

Patients with Cystic Fibrosis

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with genetically determined cystic fibrosis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christoph Saner: lead
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

University childrens hospital Basel, UKBB

Basel, 4056, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Glucose, C-Peptide, Insulin, HbA1c in blood specimen.

MeSH Terms

Conditions

Glucose Intolerance; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Christoph Saner, MD

  University childrens Hospital, UKBB, Basel Switzerland

  PRINCIPAL INVESTIGATOR

• Urs Zumsteg, Prof

  University childrens Hospital, UKBB, Basel Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: October 6, 2015
• Study Start: June 1, 2015
• Primary Completion: November 18, 2016
• Study Completion: November 18, 2016
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

CH (1)