- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02723968
Cystic Fibrosis Related Diabetes Screening. (D2M)
Sensitivity and Specificity of Different Methods for Cystic Fibrosis-related Diabetes Screening.
Cystic fibrosis-related diabetes is a late cystic fibrosis (CF) associated comorbidity whose prevalence is increasing sharply lifelong. Guidelines for glucose metabolism (GM) monitoring relies on oral glucose tolerance test . However, this test is neither sensitive nor specific.
The aim of this study is to compare sensitivity and specificity of different methods for GM monitoring in children and adolescents with CF.
Continuous GM system (CGMS) will be used as the reference method. Results will be compared to those of oral glucose tolerance test (OGTT), intravenous glucose tolerance test (IGTT), homeostasis model assessment index of insulin resistance (HOMA-%IR) , homeostasis model assessment index of beta-cell function (HOMA-%B) and HbA1C dosage (glycated haemoglobin A1C). Patients will be classified into three groups according to CGMS: normal glucose tolerance, impaired glucose tolerance and diabetes mellitus.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects with confirmed diagnosis of Cystic Fibrosis with a sweat chloride > 60 mmol/L.
- Subjects will be aged between 10 and 18 years with at least one class 1 or 2 Cystic fibrosis transmembrane conductance regulator (CFTR) mutation.
- Subjects will be pancreatic insufficient.
- Subjects must have a forced expiratory volume 1 (FEV1)> 40 % of predicted normal for age, sex and height at the screening visit.
- Stable CF disease as judged by the investigator
Exclusion Criteria:
- Subjects with glucose intolerance abnormalities
- Subjects with pulmonary exacerbation within 4 weeks before screening
- History of lung or hepatic transplantation or awaiting transplantation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Continuous glucose monitoring system
OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage
|
At the first visit at day 1an OGTT will be performed then the CGMS is implanted.
Capillary glycaemia will be taken four times a day to set up the CGMS.
A second visit is scheduled at day 4, where the intravenous glucose tolerance test is performed as well as the HbA1C level.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measurement of the sensitivity and the specificity of IGTT (intravenous glucose tolerance test) for the diagnosis of diabetes mellitus in comparison to a continuous glucose monitoring system
Time Frame: Day 3
|
Day 3
|
Measurement of the sensitivity and the specificity of HOMA-%IR (homeostasis model assessment index of insulin resistance) for the diagnosis of diabetes mellitus in comparison to a continuous glucose monitoring system.
Time Frame: Day 3
|
Day 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measurement of the prevalence of diabetes mellitus.
Time Frame: Day 3
|
Day 3
|
Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C).
Time Frame: Day 3
|
Day 3
|
Measurement of glucose intolerance
Time Frame: Day 3
|
Day 3
|
Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C).
Time Frame: Day 3
|
Day 3
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Endocrine System Diseases
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Pancreatic Diseases
- Fibrosis
- Diabetes Mellitus
- Cystic Fibrosis
- Pharmaceutical Solutions
Other Study ID Numbers
- 2008.527
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cystic Fibrosis-related Diabetes
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University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
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Rhode Island HospitalCystic Fibrosis FoundationRecruitingCystic Fibrosis | Cystic Fibrosis-related Diabetes | Cystic Fibrosis With Intestinal ManifestationsUnited States
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University of PortsmouthUniversity Hospital Southampton NHS Foundation Trust; Loughborough University; Queen Alexandra HospitalTerminated
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Boston Children's HospitalCompletedCystic Fibrosis | Cystic Fibrosis-related Diabetes | Cystic Fibrosis With Intestinal ManifestationsUnited States
-
Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
-
University of CambridgeUniversity of Oxford; University of EdinburghRecruitingCystic Fibrosis-related DiabetesUnited Kingdom
-
Jagdeesh UllalWake Forest University Health SciencesActive, not recruitingCystic Fibrosis-related DiabetesUnited States
-
Massachusetts General HospitalBeta Bionics, Inc.CompletedCystic Fibrosis-related DiabetesUnited States
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Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern... and other collaboratorsEnrolling by invitationCystic Fibrosis Related DiabetesUnited States
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Hacettepe UniversityCompletedDiabetes Mellitus | Cystic Fibrosis | Cystic Fibrosis-related DiabetesTurkey
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