D2M: Cystic Fibrosis Related Diabetes Screening.

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT02723968

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis-related Diabetes	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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Continuous glucose monitoring system OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage	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

Arm

Intervention/Treatment

Other: Continuous glucose monitoring system

OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT02723968

Other Study ID Numbers:

2008.527

First Posted:

Mar 31, 2016

Last Update Posted:

May 28, 2019

Last Verified:

Mar 1, 2016

Additional relevant MeSH terms:

Cystic Fibrosis

Diabetes Mellitus

Fibrosis

Pharmaceutical Solutions

Study Results

No Results Posted as of May 28, 2019