Cystic Fibrosis Related Diabetes Screening.

NCT02723968 | Completed

• 1 other identifier: 2008.527
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis-related Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (1)

Continuous glucose monitoring system

OTHER

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; Procedure: HGPIV diagnosis test; Procedure: HOMAR-IR diagnosis test

Interventions

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 OTHER

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.

Continuous glucose monitoring system

HGPIV diagnosis test PROCEDURE

Continuous glucose monitoring system

HOMAR-IR diagnosis test PROCEDURE

Continuous glucose monitoring system

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Subjects with glucose intolerance abnormalities
• Subjects with pulmonary exacerbation within 4 weeks before screening
• History of lung or hepatic transplantation or awaiting transplantation

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Related 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 Pediatr Endocrinol Metab. 2017 Jan 1;30(1):27-35. doi: 10.1515/jpem-2016-0184.

  PMID: 27977404 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 31, 2016
• Study Start: September 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: April 1, 2012
• Last Updated: May 28, 2019

Record last verified: 2016-03