Cystic Fibrosis Related Diabetes Screening. (D2M)
Sensitivity and Specificity of Different Methods for 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: Continuous glucose monitoring system
OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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
Tidsram: Day 3
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Day 3
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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.
Tidsram: Day 3
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Day 3
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Measurement of the prevalence of diabetes mellitus.
Tidsram: Day 3
|
Day 3
|
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Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C).
Tidsram: Day 3
|
Day 3
|
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Measurement of glucose intolerance
Tidsram: Day 3
|
Day 3
|
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Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C).
Tidsram: Day 3
|
Day 3
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- Störningar i glukosmetabolism
- Metaboliska sjukdomar
- Luftvägssjukdomar
- Lungsjukdomar
- Sjukdomar i det endokrina systemet
- Spädbarn, nyfödda, sjukdomar
- Genetiska sjukdomar, medfödda
- Bukspottkörtelsjukdomar
- Fibros
- Diabetes mellitus
- Cystisk fibros
- Farmaceutiska lösningar
Andra studie-ID-nummer
- 2008.527
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