Clinical trial NCT02627690: Nephrologic Prognosis 10 Years After Diabetes Cell Therapy
Official title: Nephrologic Prognosis 10 Years After Diabetes Cell Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Islet Transplantation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering of type 1 diabetes since at least 10 years

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Modification of Diet in Renal Disease (MDRD)
timeFrame: At 10 years
Secondary outcomes:
measure: number of cardiovascular events
timeFrame: At 10 years
measure: number of deaths
timeFrame: At 10 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital
Study officials:
affiliation: Lille University Hospital
name: Marie-Christine VANTYGHEM, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: