Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

Study Overview
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Brief Summary
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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

Official Title
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Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

Conditions
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Islet Transplantation

Intervention / Treatment
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* Other: islet transplanted
* Other: non islet transplanted


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Islet transplanted<br>patients who underwent islet transplantation | Other: islet transplanted<br>* islet transplantation<br>* Other names: Islet transplantation;|
| non islet transplanted<br>patients who refused or were non selected for islet transplantation for a non nephrologic reason | Other: non islet transplanted<br>* no islet transplantation (for a non nephrologic reason)<br>* Other names: no islet transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of Diet in Renal Disease (MDRD) | measure the difference of Modification of Diet in Renal Disease (MDRD) between the two groups according to the presence or absence of an islet transplant. | At 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of cardiovascular events |  | At 10 years | 
| number of deaths |  | At 10 years |