Cystic Fibrosis-related Diabetes Clinical Trial
— D2MOfficial title:
Sensitivity and Specificity of Different Methods for Cystic Fibrosis-related Diabetes Screening.
NCT number | NCT02723968 |
Other study ID # | 2008.527 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2009 |
Est. completion date | April 2012 |
Verified date | March 2016 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | April 2012 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
Mainguy C, Bellon G, Delaup V, Ginoux T, Kassai-Koupai B, Mazur S, Rabilloud M, Remontet L, Reix P. Sensitivity and specificity of different methods for cystic fibrosis-related diabetes screening: is the oral glucose tolerance test still the standard? J P — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Day 3 | ||
Primary | 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. | Day 3 | ||
Secondary | Measurement of the prevalence of diabetes mellitus. | Day 3 | ||
Secondary | Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C). | Day 3 | ||
Secondary | Measurement of glucose intolerance | Day 3 | ||
Secondary | Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C). | Day 3 |
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