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ACTIVE NOT RECRUITING
NCT07250607

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

Sponsor: Azienda Ospedaliero, Universitaria Pisana

View on ClinicalTrials.gov

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

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