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Glucose Tolerance in Children With Cystic Fibrosis (GluTolCF)

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ClinicalTrials.gov Identifier: NCT02569229
Recruitment Status : Active, not recruiting
First Posted : October 6, 2015
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Christoph Saner, University Hospital, Basel, Switzerland

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
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.


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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 : June 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Dextrose

Group/Cohort 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.
  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.




Primary Outcome Measures :
  1. % 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 ]
    These measurements will be gained out of the 7 day CGMS-course (continuous glucose monitoring system).

  2. 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 ]
    Standard oral glucose tolerance test.

  3. 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 ]
    Standard intravenous glucose tolerance test.

  4. 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 ]
  5. Lung clearance index [ Time Frame: Within 3 months of the 7 day course of CGMS ]
  6. BMI-SDS (standard deviation score). [ Time Frame: At day 1 of the CGMS course ]
  7. HbA1c [ Time Frame: Within the 7 day course of CGMS ]

Secondary Outcome Measures :
  1. Comparing the performance between CGMS and OGTT related to clinical parameters. [ Time Frame: 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:
  1. Characterising glucose profiles over 24 hours [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Glucose, C-Peptide, Insulin, HbA1c in blood specimen.


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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with genetically determined cystic fibrosis.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569229


Locations
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Switzerland
University childrens hospital Basel, UKBB
Basel, Switzerland, 4056
Sponsors and Collaborators
Christoph Saner
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Christoph Saner, MD University childrens Hospital, UKBB, Basel Switzerland
Study Director: Urs Zumsteg, Prof University childrens Hospital, UKBB, Basel Switzerland

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Responsible Party: Christoph Saner, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02569229     History of Changes
Other Study ID Numbers: EKNZ 2015-143
KEK BE: 102/15 ( Other Identifier: Ethics commitee of attending study site )
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Keywords provided by Christoph Saner, University Hospital, Basel, Switzerland:
children
cystic fibrosis
glucose intolerance
continuous glucose measurement
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Glucose Intolerance
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases