Predicting diabetes outcomes after a kidney transplant
Post-Transplant Diabetes Outcomes Prediction Through Machine Learning and Deep Phenotyping
This project will try to see if whole genome sequencing can help predict outcomes for adults who develop new diabetes after a kidney transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT07512804 on ClinicalTrials.gov |
What this trial studies
Adults who received a kidney transplant and developed new-onset diabetes 1 to 10 years later will undergo whole genome sequencing and clinical data collection at a single center in Rome. Researchers will compare genetic findings with patients' clinical courses to look for genetic patterns linked to complications and long-term outcomes. Participants with active cancer, active infection, recurrent biopsy-proven renal disease, severe heart failure (NYHA III-IV), or hepatic failure are excluded. The goal is to identify genetic predictors that could guide personalized post-transplant diabetes management.
Who should consider this trial
Good fit: Adults aged 18 to 70 who received a kidney transplant and were diagnosed with new-onset post-transplant diabetes between 1 and 10 years before enrollment, and who can give informed consent, are ideal candidates.
Not a fit: Patients with active cancer, active infection, prior recurrent biopsy-proven renal disease, severe heart failure, or hepatic failure are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could help doctors predict which transplant recipients are at higher risk for complications and tailor follow-up and treatment more precisely.
How similar studies have performed: Some prior genetic studies have suggested links between variants and diabetes risk, but using whole genome sequencing specifically to predict post-transplant diabetes outcomes is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age between 18 and 70 years old, * kidney graft recipients with a diagnosis of de novo post-transplant diabetes between 1 and 10 years from the time of enrollment, * ability to sign a valid informed consent form. Exclusion Criteria: * diagnosis of neoplasia, * the presence of an active infection, * previous biopsy-proven diagnosis of a recurrent renal disease, * NYHA class III-IV heart failure, * hepatic failure.
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Nefrologia — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe Grandaliano — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Giuseppe Grandaliano
- Email: giuseppe.grandaliano@unicatt.it
- Phone: +390630159983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.