Clinical trial NCT02723968: Cystic Fibrosis Related Diabetes Screening.
Official title: Sensitivity and Specificity of Different Methods for Cystic Fibrosis-related Diabetes Screening.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis-related Diabetes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 29
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Day 3
measure: 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.
timeFrame: Day 3
Secondary outcomes:
measure: Measurement of the prevalence of diabetes mellitus.
timeFrame: Day 3
measure: Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C).
timeFrame: Day 3
measure: Measurement of glucose intolerance
timeFrame: Day 3
measure: Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C).
timeFrame: Day 3
Other outcomes:
Locations:
Study officials:
References:
citation: 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 Pediatr Endocrinol Metab. 2017 Jan 1;30(1):27-35. doi: 10.1515/jpem-2016-0184.