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Cystic Fibrosis Related Diabetes Screening. (D2M)

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ClinicalTrials.gov Identifier: NCT02723968
Recruitment Status : Completed
First Posted : March 31, 2016
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
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 : September 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications of Results:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02723968     History of Changes
Other Study ID Numbers: 2008.527
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: March 2016

Additional relevant MeSH terms:
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Diabetes Mellitus
Fibrosis
Cystic Fibrosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases