NCT02627690

Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years – 77 Years
• Healthy volunteers: Not accepted

Summary

Islet transplantation for type 1 diabetes results are still improving, and actually Insulin-independence with normal HbA1c is obtained in 50% of patients after 5 years, 80% of c-peptide positive patients. In addition to the need of 2 or 3 surgical or radiological interventions to inject islets, an immunosuppressive regimen is needed, which can be deleterious, particularly on kidneys. Moreover, long term beneficial effects of islet transplantation on stabilization or prevention of macro and micro vascular complications of diabetes has not been evaluated. In a preliminary work, it was observed a stabilisation or improvement of microvascular complications when compared to pre-transplant data. The aim of this study is to compare the evolution of diabetes complications, especially nephrologic, 10 years after islet transplantation and to compare it to patients with a brittle diabetes, 10 years after evaluation for islet transplantation, finally not performed. This case-control study will evaluate nephrologic parameters (creatinine, MDRD creatinine clearance, microalbuminuria, proteinuria) and other micro and macro-vascular complications of type 1 diabetes) before islet transplantation and 10 years after the transplantation or after the first evaluation in patients who finally did not underwent islet transplantation for various non nephrologic reasons

Conditions

• Islet Transplantation

Interventions

Type	Name	Description
OTHER	islet transplanted	islet transplantation
OTHER	non islet transplanted	no islet transplantation (for a non nephrologic reason)

Timeline

• Start date: 2014-11-03
• Primary completion: 2021-11-29
• Completion: 2021-11-29
• First posted: 2015-12-11
• Last updated: 2022-04-29

Locations

1 site across 1 country: France