Cystic Fibrosis Related Diabetes Screening.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02723968
• Date of registration: 21/03/2016
• Prospective Registration: No
• Primary sponsor: Hospices Civils de Lyon
• Public title: Cystic Fibrosis Related Diabetes Screening. D2M
• Scientific title: Sensitivity and Specificity of Different Methods for Cystic Fibrosis-related Diabetes Screening.
• Date of first enrolment: September 2009
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02723968
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
• Phase: N/A

Key inclusion & exclusion criteria

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



Age minimum: 10 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis-related Diabetes

Intervention(s)

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

Primary Outcome(s)

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. [Time Frame: Day 3]

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 [Time Frame: Day 3]

Secondary Outcome(s)

Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C). [Time Frame: Day 3]

Measurement of the prevalence of diabetes mellitus. [Time Frame: Day 3]

Measurement of glucose intolerance [Time Frame: Day 3]

Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C). [Time Frame: Day 3]

Secondary ID(s)

2008.527

Source(s) of Monetary Support

Please refer to primary and secondary sponsors