title: The "Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes": Study protocol.
abstract: OBJECTIVE
  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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT02311244; URL https://clinicaltrials.gov/ct2/show/NCT02311244?term=SUMMER&rank=5.
authors.affiliation: Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.
authors.forename: I
authors.initials: I
authors.lastname: Barchetta
authors.affiliation: Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Capoccia
authors.affiliation: Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
authors.forename: M G
authors.initials: MG
authors.lastname: Baroni
authors.affiliation: Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Buzzetti
authors.affiliation: Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.
authors.forename: M G
authors.initials: MG
authors.lastname: Cavallo
authors.affiliation: IRCSS Casa Sollievo della Sofferenza, Department of Medicine, San Giovanni Rotondo, Italy.
authors.forename: S
authors.initials: S
authors.lastname: De Cosmo
authors.affiliation: Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Leonetti
authors.affiliation: Unit of Diabetology, Ospedale Sandro Pertini, Rome, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Leotta
authors.affiliation: Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Morano
authors.affiliation: Unit of Diabetology, Ospedale San Camillo Forlanini, Rome, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Morviducci
authors.affiliation: IRCCS Casa Sollievo della Sofferenza, Mendel-Laboratory, San Giovanni Rotondo, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Prudente
authors.affiliation: Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Pugliese
authors.affiliation: Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy; IRCCS Casa Sollievo della Sofferenza, Mendel-Laboratory, San Giovanni Rotondo, Italy. Electronic address: vincenzo.trischitta@uniroma1.it.
authors.forename: V
authors.initials: V
authors.lastname: Trischitta
mesh_terms: D018070:Biological Specimen Banks; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000235:genetics / Q000378:metabolism / Q000401:mortality*; D002423:Cause of Death; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000235:genetics / Q000378:metabolism / Q000401:mortality*; D015340:Epidemiologic Research Design; D020869:Gene Expression Profiling; D005819:Genetic Markers; D023281:Genomics / Q000379:methods; D006801:Humans; D007558:Italy / Q000453:epidemiology; D055432:Metabolomics / Q000379:methods; D011446:Prospective Studies; D012307:Risk Factors; D012621:Seasons; D013997:Time Factors
chemical_list: D005819:Genetic Markers
keywords: Bio bank; Death rate; Omics signatures; Type 2 diabetes