NCT02723968

Cystic Fibrosis Related Diabetes Screening.

Sensitivity and Specificity of Different Methods for Cystic Fibrosis-related Diabetes Screening.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis-related Diabetes

Interventions

Type	Name	Description
OTHER	glucose 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.
PROCEDURE	HGPIV diagnosis test
PROCEDURE	HOMAR-IR diagnosis test

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-09-01
• Completion: 2012-04-01
• First posted: 2016-03-31
• Last updated: 2019-05-28