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Cosma, Chiara (2013) Diagnosi di diabete: è sufficiente l'HbA1c? [Tesi di dottorato]

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Abstract (inglese)

Background: Glycated haemoglobin (HbA1c) is considered the ‘gold standard’ for monitoring metabolic control in diabetes. New diagnostic criteria have been proposed by the American Diabetes Association (ADA) focusing on A1C for diagnosis of diabetes as well as for identification of the subjects at increased risk, being values ≥6,5% (48 mmol/mol) diagnostic for diabetes and values between 5,7 - 6,4% , (39- 47 mmol/mol) suggestive of a pre-diabete condition. Measuring HbA1c has several advantages over glucose measurements, but its particular adoption should be considered only if the test is carried out under standardised conditions taking into account its limitations, the impact of measurement on the epidemiology of diabetes and other categories of glucose intolerance is widely discussed.
Research design and Methods: The study, started on April 2010, includes all subjects presenting to outpatients department with request of OGTT in which the diagnostic performance of new proposed criteria and standard 75-g oral glucose tolerance test (OGTT) has been compared. Until now 498 subjects (males n=194, females n= 304, mean age (51,17±15,49)years) have been enrolled. Plasma glucose, lipid profile and creatinine have been measured using Cobas 8000, (Roche Diagnostics); Hb A1C with HPLC procedure (Adams HA-8180 Arkray, Kyoto, Japan) and serum insulin with Immulite 2000 (Simens).
Results: OGTTs has identified pre-diabetic condition in 21.48% of subjects (n=107) while new diagnostic criteria in 40,16% (n=200), being serum insulin, mean 3,17 U/L and 4,764 U/L and HOMA index, mean 0.95 and 1.240 respectively. The diagnosis of diabetes occurred in 18,27% of subjects (n=91, mean serum insulin 5,9 U/L), vs 6.62% (n=33, mean serum insulin 4,92 U/L) according to OGTT and new proposed criteria respectively. The HOMA index were respectively 1.76 and 1.53.
Conclusion: The data obtained in our study evidence that the proposed new diagnostic criteria are questionable because 11,65 % of diabetes’s cases are misclassified

Abstract (italiano)

Introduzione: L'€™emoglobina glicata è considerate il "€œgold-standard"€ per il monitoraggio del paziente diabetico. American Diabetes Association (ADA) ha proposto dei nuovi criteri diagnostici per il diabete basati sull’ utilizzo dell’ HbA1c. , ponendo questi cut-off : HbA1c ≥6,5% (48 mmol/mol) diagnosi di diabete, HbA1c tra 5,7 - 6,4% , (39- 47 mmol/mol) condizione di pre-diabete mentre HbA1c ≤5,6% (≤38 mmol/mol) condizione normale. La misura dell'HbA1c presenta una serie di vantaggi rispetto alla misura del glucosio, ma la sua adozione come test per fare diagnosi dovrebbe essere considerata solo se tale test è standardizzato IFCC.
Scopo : Lo scopo del presente lavoro è stato quello di valutare se HbA1c poteva sostituire per la diagnosi di diabete la classica OGTT.
Materiali e Metodi: Questo studio è iniziato nell'Aprile 2010; Sono stati reclutati tutti i pazienti che provenivano presso gli Ambulatori di via San Massimo con richiesta di OGTT. A questi pazienti, sottoconsenso informato, è stata prelevata una provetta aggiuntiva per l'analisi dell'HbA1c.
Sono state coinvolte 498 persone, 194 maschi e 304 femmine con un età media di 51,17 anni. A tutte queste persone oltre all'OGTT e HbA1c sono stati misurati la creatinina ( indice di funzionalità renale), profilo lipidico (colesterolo totale, HDL, LDL e trigliceridi) e insulina per il calcolo dell’ HOMA Index ( indice di insulino resistenza).
L'HbA1c è misurata da un HPLC (Adams HA-8180 Arkray, Kyoto, Japan) l'€™OGTT, creatinina, profile lipidico dallo Strumento Cobas 8000 ( Roche Diagnostics) e l'™insulina dallo strumento Immulite 2000 ( Simens).
Risultati: l'OGTT ha identificato una condizione prediabetica nel 21,48% dei soggetti (N= 107) sebbene i nuovi criteri ADA l'€™abbiano identificata nel 40,16% (N=200), la media dell'€™insulina è 3,17 U/L e 4,764 U/L rispettivamente e la media dell'HOMA index di 0.95 e 1,240 rispettivamente.
La diagnosi di diabete, invece, è identificata nel 18,27% dei soggetti (N=91, la media dell'€™insulina è 5,9 U/L) vs 6,62% (N=33, media dell'€™insulina 4,92 U/L), accordando rispettivamente con i criteri OGTT vs ADA. The Homa index furono in media di 1,76 e 1,53 , rispettivamente.
Conclusioni: i nostri dati dimostrano che i nuovi criteri per la diagnosi di diabete risultano, al momento, questionabili in quanto, 11,65% dei soggetti della nostra coorte risultano essere misclassificati

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Tipo di EPrint:Tesi di dottorato
Relatore:Lapolla, Annunziata - Plebani, Mario
Dottorato (corsi e scuole):Ciclo 25 > Scuole 25 > SCIENZE MEDICHE, CLINICHE E SPERIMENTALI > METODOLOGIA CLINICA, SCIENZE ENDOCRINOLOGICHE E DIABETOLOGICHE
Data di deposito della tesi:23 Gennaio 2013
Anno di Pubblicazione:26 Gennaio 2013
Parole chiave (italiano / inglese):HbA1c, emoglobina glicata, IFG, alterata glicemia a digiuno, IGT ridotta tolleranza al glucosio
Settori scientifico-disciplinari MIUR:Area 06 - Scienze mediche > MED/13 Endocrinologia
Struttura di riferimento:Dipartimenti > Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari
Codice ID:5434
Depositato il:08 Ott 2013 15:28
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