Document Detail


A large multi-centre European study validates high-sensitivity C-reactive protein (hsCRP) as a clinical biomarker for the diagnosis of diabetes subtypes.
MedLine Citation:
PMID:  21814873     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS/HYPOTHESIS: An accurate molecular diagnosis of diabetes subtype confers clinical benefits; however, many individuals with monogenic diabetes remain undiagnosed. Biomarkers could help to prioritise patients for genetic investigation. We recently demonstrated that high-sensitivity C-reactive protein (hsCRP) levels are lower in UK patients with hepatocyte nuclear factor 1 alpha (HNF1A)-MODY than in other diabetes subtypes. In this large multi-centre study we aimed to assess the clinical validity of hsCRP as a diagnostic biomarker, examine the genotype-phenotype relationship and compare different hsCRP assays.
METHODS: High-sensitivity CRP levels were analysed in individuals with HNF1A-MODY (n = 457), glucokinase (GCK)-MODY (n = 404), hepatocyte nuclear factor 4 alpha (HNF4A)-MODY (n = 54) and type 2 diabetes (n = 582) from seven European centres. Three common assays for hsCRP analysis were evaluated. We excluded 121 participants (8.1%) with hsCRP values >10 mg/l. The discriminative power of hsCRP with respect to diabetes aetiology was assessed by receiver operating characteristic curve-derived C-statistic.
RESULTS: In all centres and irrespective of the assay method, meta-analysis confirmed significantly lower hsCRP levels in those with HNF1A-MODY than in those with other aetiologies (z score -21.8, p < 5 × 10(-105)). HNF1A-MODY cases with missense mutations had lower hsCRP levels than those with truncating mutations (0.03 vs 0.08 mg/l, p < 5 × 10(-5)). High-sensitivity CRP values between assays were strongly correlated (r (2) ≥ 0.91, p ≤ 1 × 10(-5)). Across the seven centres, the C-statistic for distinguishing HNF1A-MODY from young adult-onset type 2 diabetes ranged from 0.79 to 0.97, indicating high discriminative accuracy.
CONCLUSIONS/INTERPRETATION: In the largest study to date, we have established that hsCRP is a clinically valid biomarker for HNF1A-MODY in European populations. Given the modest costs and wide availability, hsCRP could translate rapidly into clinical practice, considerably improving diagnosis rates in monogenic diabetes.
Authors:
G Thanabalasingham; N Shah; M Vaxillaire; T Hansen; T Tuomi; D Gašperíková; M Szopa; E Tjora; T J James; P Kokko; F Loiseleur; E Andersson; S Gaget; B Isomaa; N Nowak; H Raeder; J Stanik; P R Njolstad; M T Malecki; I Klimes; L Groop; O Pedersen; P Froguel; M I McCarthy; A L Gloyn; K R Owen
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't; Validation Studies     Date:  2011-08-04
Journal Detail:
Title:  Diabetologia     Volume:  54     ISSN:  1432-0428     ISO Abbreviation:  Diabetologia     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-10-07     Completed Date:  2012-03-01     Revised Date:  2012-05-23    
Medline Journal Info:
Nlm Unique ID:  0006777     Medline TA:  Diabetologia     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  2801-10     Citation Subset:  IM    
Affiliation:
Oxford Centre for Diabetes Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Headington, Oxford, OX3 7LJ, UK.
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MeSH Terms
Descriptor/Qualifier:
Adult
Age of Onset
Biological Markers / blood
C-Reactive Protein / analysis*
Diabetes Mellitus, Type 2 / blood*,  diagnosis,  genetics*
Europe
Glucokinase / chemistry,  genetics
Hepatocyte Nuclear Factor 1-alpha / chemistry,  genetics*
Hepatocyte Nuclear Factor 4 / chemistry,  genetics
Heterozygote
Humans
Meta-Analysis as Topic
Middle Aged
Molecular Diagnostic Techniques*
Mutation
Reproducibility of Results
Sensitivity and Specificity
Young Adult
Grant Support
ID/Acronym/Agency:
G0700222(81696)//Medical Research Council
Chemical
Reg. No./Substance:
0/Biological Markers; 0/HNF1A protein, human; 0/HNF4A protein, human; 0/Hepatocyte Nuclear Factor 1-alpha; 0/Hepatocyte Nuclear Factor 4; 9007-41-4/C-Reactive Protein; EC 2.7.1.2/Glucokinase

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