Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

NCT ID: NCT02627690

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-03
• Study Completion Date: 2021-11-29

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

Conditions

Islet Transplantation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Islet transplanted

patients who underwent islet transplantation

islet transplanted

Intervention Type: OTHER

islet transplantation

non islet transplanted

patients who refused or were non selected for islet transplantation for a non nephrologic reason

non islet transplanted

Intervention Type: OTHER

no islet transplantation (for a non nephrologic reason)

Interventions

islet transplanted

islet transplantation

Intervention Type: OTHER

non islet transplanted

no islet transplantation (for a non nephrologic reason)

Intervention Type: OTHER

Other Intervention Names

Islet transplantation; no islet transplantation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Christine VANTYGHEM, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lille University Hospital

Locations

Lille University Hospital

Lille, , France

Countries

France

Other Identifiers

2014-A00141-46

Identifier Type: OTHER

Identifier Source: secondary_id

2013_28

Identifier Type: -

Identifier Source: org_study_id