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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Continuous glucose monitoring system
OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: Day 3
|
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.
Tidsramme: Day 3
|
Day 3
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Measurement of the prevalence of diabetes mellitus.
Tidsramme: Day 3
|
Day 3
|
|
Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C).
Tidsramme: Day 3
|
Day 3
|
|
Measurement of glucose intolerance
Tidsramme: Day 3
|
Day 3
|
|
Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C).
Tidsramme: Day 3
|
Day 3
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Luftvejssygdomme
- Lungesygdomme
- Sygdomme i det endokrine system
- Spædbarn, Nyfødt, Sygdomme
- Genetiske sygdomme, medfødte
- Pancreassygdomme
- Fibrose
- Diabetes mellitus
- Cystisk fibrose
- Farmaceutiske løsninger
Andre undersøgelses-id-numre
- 2008.527
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