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Completed

NCT Number: NCT02723968

Cystic Fibrosis Related Diabetes Screening.

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.

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Key information

Conditions

Cystic Fibrosis-related Diabetes

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

HGPIV diagnosis test

Procedure

HOMAR-IR diagnosis test

Procedure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Measurement of the prevalence of diabetes mellitus.

    Time frame: Day 3

  2. Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C).

    Time frame: Day 3

  3. Measurement of glucose intolerance

    Time frame: Day 3

  4. Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C).

    Time frame: Day 3

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: D2M

Important dates

Study start
2009
Primary completion
2009
Study completion
2012
First posted
Mar 31, 2016
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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