NCT07250607Active, not recruiting
Extreme Phenotypes to Identify Susceptibility of Patients Living With Type 2 to Diabetes Related Complications
Extreme Phenotypes to Identify the Patients With Type 2 Diabetes Who Are Susceptible or Resistant to Complications and to Reveal the Mechanisms
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- May 2024
- Primary completion date
- Nov 2025
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Diseases
- Type 2 diabetes
- NCT number
- NCT07250607
What you commit to
- Study type: Observational
- Planned participants: 1000
- From May 2024 to the primary completion date, Nov 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of forms of diabetes other than T2D
- Any chronic inflammatory diseases or active cancer
- Any other life expectancy-changing systemic disease.
Lab values
- Significant liver disfunction (cirrhosis, AST/ALT \> 3-fold normality range, total bilirubin \> 1,5-fold normal range w/o Gilbert syndrome)
Who the study is looking for
- Type 2 Diabetes
- Age 40-80 years old
- Comprehensive screening for DRC within 24 months from the inclusion in the survey.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico Consorziale di Bari Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Azienda Rilievo Nazionale Alta Specialità (ARNAS) Garibaldi Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
Related publications
- Quantifying the individual disease duration-adjusted burden of complications in persons with type 2 diabetes.Nutr Metab Cardiovasc Dis · 2026 · PMID 42000246
This page is information, not medical advice. Discuss any trial with your doctor.