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NCT07250607: EXTREME-T2D

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

Active, enrolled Last updated 26 November 2025
What this trial tests

trial in Diabete Type 2 in 1,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 May 2024
Primary endpoint
30 November 2025
31 July 2026

Quick facts

Lead sponsorAzienda Ospedaliero, Universitaria Pisana
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment1,000
Start date1 May 2024
Primary completion30 November 2025
Estimated completion31 July 2026
Sites3 locations across Italy

Conditions studied

Sponsor

Azienda Ospedaliero, Universitaria Pisana — full company profile →

Who can join

Adults 40 to 80, any sex, with Diabete Type 2 or Diabetes Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Quantifying the individual disease duration-adjusted burden of complications in persons with type 2 diabetes.
    Sacchetta L, Gallo S, Chiriacò M, Tumino D, et al · · 2026 · PMID 42000246 · DOI 10.1016/j.numecd.2026.104716

Verify or expand the search:

Other recruiting trials for Diabete Type 2

Currently open trials in the same condition.

Other Azienda Ospedaliero, Universitaria Pisana trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07250607.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing