Nephrologic Prognosis 10 Years After Diabetes Cell Therapy (PRONOCELDIAB)

University Hospital, Lille

Status

Completed

Conditions

Islet Transplantation

Treatments

Other: islet transplanted

Other: non islet transplanted

Study type

Observational

Funder types

Other

Identifiers

NCT02627690

2014-A00141-46 (Other Identifier)

2013_28

Details and patient eligibility

About

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

Enrollment

45 patients

Sex

All

Ages

18 to 77 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 diabetic patients, with or without previous renal transplantation who benefit at least 5 years before the inclusion of clinical evaluation in order to perform an islet transplantation
Who either benefit of islet transplantation or did not and treated with optimized insulin therapy

Exclusion criteria

C-peptide positive diabetes
Type 1 diabetic patient non-grafted of islets due to albuminuria> 300mg / 24h or MDRD <50 ml / min during the pre-transplant evaluation (exclusion criterion for islet transplantation)
Patients that can not receive clear information
Refusal to sign the consent
Psychiatric Pathology
Participation in another study excluding the possibility of participating in another protocol.
Pregnant or breast feeding women
Patients under guardianship, persons deprived of freedom
Lack of coverage by the social security system