Cystic Fibrosis Related Diabetes Screening.

Cystic Fibrosis-related Diabetes Clinical Trial

— D2M  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723968
• Other study ID #: 2008.527
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: April 2012

Study information

• Verified date: March 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis-related Diabetes
• Diabetes Mellitus
• Fibrosis

Intervention

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

• HOMAR-IR diagnosis test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

References & Publications (1)

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

Outcome

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