The 'Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes': Study protocol
| Autor: | Danila Capoccia, Giorgio Basile, Laura Bertoccini, Mara Fallarino, Maria Gisella Cavallo, Massimiliano Copetti, S. De Cosmo, Marco Giorgio Baroni, S. Leotta, C. Pibiri, Raffaella Buzzetti, Paola D'Angelo, Diego Bailetti, Susanna Morano, Ilaria Barchetta, Giuseppe Pugliese, Frida Leonetti, Vincenzo Trischitta, E Alessi, Sabrina Prudente, L. Morviducci |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Genetic Markers
medicine.medical_specialty Time Factors Bio bank Death rate Omics signatures Type 2 diabetes Medicine (miscellaneous) Nutrition and Dietetics Endocrinology Diabetes and Metabolism Cardiology and Cardiovascular Medicine 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Endocrinology Risk Factors Cause of Death Diabetes mellitus medicine Risk of mortality Humans Metabolomics Prospective Studies 030212 general & internal medicine Diabetes and Metabolism Biological Specimen Banks business.industry Gene Expression Profiling Mortality rate Type 2 Diabetes Mellitus Genomics Odds ratio medicine.disease Surgery Diabetes Mellitus Type 2 Italy Cardiovascular Diseases Epidemiologic Research Design Emergency medicine Observational study Seasons business Body mass index |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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