Cystic Fibrosis Related Diabetes Screening.

Not Applicable

Completed

• Conditions: Cystic Fibrosis-related Diabetes
• Interventions: 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; Procedure: HGPIV diagnosis test; Procedure: HOMAR-IR diagnosis test

• Registration Number: NCT02723968
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2012-04
• Status Verified: 2016-03
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-31
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous glucose monitoring system	HOMAR-IR diagnosis test	OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage
Continuous glucose monitoring system	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	OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage
Continuous glucose monitoring system	HGPIV diagnosis test	OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Measurement of glucose intolerance	Day 3
Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C).	Day 3
Measurement of the prevalence of diabetes mellitus.	Day 3
Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C).	Day 3