The "Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes": Study protocol

Area of Science:

• Cardiovascular research
• Diabetes mellitus research
• Molecular epidemiology

Background:

• Diabetic patients face double the mortality risk, particularly from cardiovascular causes, compared to non-diabetics.
• Understanding the molecular drivers of mortality and vascular events in type 2 diabetes mellitus (T2DM) is crucial for targeted prevention and treatment.
• The "Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in diabetes" addresses this critical need.

Purpose of the Study:

• To identify novel molecular promoters of mortality and major vascular events in patients with T2DM.
• To unravel new pathogenic pathways underlying mortality and vascular morbidity in T2DM.
• To develop improved risk prediction models and personalized treatment strategies for T2DM.

Main Methods:

• An observational, prospective, collaborative study involving at least 5000 T2DM patients.
• Minimum 5-year follow-up period across multiple diabetes clinics in Central-Southern Italy.
• Creation of a biobank for comprehensive genomic, transcriptomic, and metabolomic analyses to discover molecular predictors.

Main Results:

• This section is not available in the provided abstract.

Conclusions:

• The SUMMER study aims to identify new molecular factors influencing mortality and vascular events in T2DM.
• These factors will elucidate underlying pathogenic mechanisms and serve as biomarkers for risk prediction.
• Findings will inform the development of novel preventive and therapeutic strategies, potentially tailored to individual patient profiles.