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Extreme Phenotypes to Identify Susceptibility of Patients Living With Type 2 to Diabetes Related Complications
Sponsor: Azienda Ospedaliero, Universitaria Pisana
Summary
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.
Official title: Extreme Phenotypes to Identify the Patients With Type 2 Diabetes Who Are Susceptible or Resistant to Complications and to Reveal the Mechanisms
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2024-05-01
Completion Date
2026-07-31
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Locations (3)
Policlinico Consorziale di Bari
Bari, BA, Italy
Azienda Rilievo Nazionale Alta Specialità (ARNAS) Garibaldi
Catania, CT, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, PI, Italy