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NCT07250607: EXTREME-T2D
Extreme Phenotypes to Identify Susceptibility of Patients Living With Type 2 to Diabetes Related Complications
trial in Diabete Type 2 in 1,000 participants. Participants enrolled and being followed up; not accepting new ones.
30 November 2025
Quick facts
| Lead sponsor | Azienda Ospedaliero, Universitaria Pisana |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 1 May 2024 |
| Primary completion | 30 November 2025 |
| Estimated completion | 31 July 2026 |
| Sites | 3 locations across Italy |
Conditions studied
- Diabete Type 2 — all drugs for Diabete Type 2 →
- Diabetes Complications — all drugs for Diabetes Complications →
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):
-
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:
- PubMed search for NCT07250607
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07250607 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda Ospedaliero, Universitaria Pisana
- Last refreshed: 26 November 2025
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