Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

Completed

• Conditions: Islet Transplantation
• Interventions: Other: islet transplanted; Other: non islet transplanted

• Registration Number: NCT02627690
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-03
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-11
• Primary Completion: 2021-11-29
• Study Completion: 2021-11-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Islet transplanted	islet transplanted	patients who underwent islet transplantation
non islet transplanted	non islet transplanted	patients who refused or were non selected for islet transplantation for a non nephrologic reason

Primary Outcome Measures

Name	Time	Method
Modification of Diet in Renal Disease (MDRD)	At 10 years	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.

Secondary Outcome Measures

Name	Time	Method
number of deaths	At 10 years
number of cardiovascular events	At 10 years

Trial Locations

Locations (1)

Lille University Hospital; 🇫🇷 Lille, France