Extreme Phenotypes to Identify Susceptibility of Patients Living With Type 2 to Diabetes Related Complications

The goal of this observational study is to learn more about the diverse susceptibility to micro and macrovascular complications in individuals living with Type 2 Diabetes (T2D). The main questions of the study are: * Is the chronic exposure to hyperglycemia the only determinant of diverse susceptibility to diabetes related complications (DRC) across the T2D population? * Is it possible to develop a reliable tool to identify patients at different susceptibility to DRC? * Is it possible to predict DRC susceptibility through biomarkers in the field of inflammation, hormonal signaling or non-coding circulating nucleotides. People living with T2D and well screened for complications according to the international recommendations (American Diabetes Association/European Society for the study of Diabetes) will be included in the survey collecting information about chronic exposure to hyperglycemia (diabetes duration + glycemic control) and incidence and severity of each macro and microvascular complication. Based on the survey result, a clinical score will be proposed to distinguish patient at different susceptibility to complications. Then, patients with extreme phenotypes of susceptibility (i.e. those with highest susceptibility for their short exposure to hyperglycemia vs those with lowest susceptibility to complication for their long exposure to hyperglycemia) will be recruited to perform a blood drawn and investigate whether preidentified potential biomarkers could describe the diverse susceptibility to DRC by showing a significant gradient between groups.

NCT Number	NCT07250607
Lead Sponsor	Azienda Ospedaliero, Universitaria Pisana
Conditions	Diabete Type 2, Diabetes Complications
Enrollment	1,000 participants
Start Date	2024-05-01
Primary Completion	2025-11-30 (estimated)
Study Completion	2026-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-26