The "Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes": Study protocol.
Nutr Metab Cardiovasc Dis
; 26(2): 103-8, 2016 Feb.
Article
em En
| MEDLINE
| ID: mdl-26698225
ABSTRACT
BACKGROUND AND AIMS:
The rate of mortality in diabetic patients, especially of cardiovascular origin, is about twice as much that of nondiabetic individuals. Thus, the pathogenic factors shaping the risk of mortality in such patients must be unraveled in order to target intensive prevention and treatment strategies. The "Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes" is aimed at identifying new molecular promoters of mortality and major vascular events in patients with type 2 diabetes mellitus (T2DM). METHODS/DESIGN:
The "SUMMER study in diabetes" is an observational, prospective, and collaborative study conducted on at least 5000 consecutive patients with T2DM, recruited from several diabetes clinics of Central-Southern Italy and followed up for a minimum of 5 years. The primary outcome is all-cause mortality; the secondary outcomes are cardiovascular mortality, acute myocardial infarction, stroke, and dialysis. A biobank will be created for genomic, transcriptomic, and metabolomic analysis, in order to unravel new molecular predictors of mortality and vascular morbidity.DISCUSSION:
The "SUMMER study in diabetes" is aimed at identifying new molecular promoters of mortality and major vascular events in patients with T2DM. These novel pathogenic factors will most likely be instrumental in unraveling new pathways underlying such dramatic events. In addition, they will also be used as additional markers to increase the performance of the already existing risk-scoring models for predicting the above-mentioned outcomes in T2DM, as well as for setting up new preventive and treatment strategies, possibly tailored to specific pathogenic backgrounds. TRIAL REGISTRATION ClinicalTrials.gov, NCT02311244; URL https//clinicaltrials.gov/ct2/show/NCT02311244?term=SUMMER&rank=5.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Estações do Ano
/
Doenças Cardiovasculares
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Diabetes Mellitus Tipo 2
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
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Etiology_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Humans
País/Região como assunto:
Europa
Idioma:
En
Revista:
Nutr Metab Cardiovasc Dis
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
/
CIENCIAS DA NUTRICAO
/
METABOLISMO
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Itália