Cystic Fibrosis-related Diabetes
Conditions
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.
Interventions
OTHERglucose solution at a dose of 1.75 g/kg (up to a maximum of 75 g) for the OGTT and glucose solution at a dose of 0.5 g/kg (up to a maximum of 35 g) was injected in 2.5-3 min for the IGTT
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.
PROCEDUREHGPIV diagnosis test
PROCEDUREHOMAR-IR diagnosis test
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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 | 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. | Day 3 |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of the prevalence of diabetes mellitus. | Day 3 |
| Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C). | Day 3 |
| Measurement of glucose intolerance | Day 3 |
| Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C). | Day 3 |
Outcome results
None listed