Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

Islet Transplantation Clinical Trial

— PRONOCELDIAB  

Official title:

Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627690
• Other study ID #: 2013_28
• Secondary ID: 2014-A00141-46
• Status: Completed
• Start date: November 3, 2014
• Est. completion date: November 29, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Islet Transplantation

Intervention

Other:
• islet transplanted
islet transplantation
• non islet transplanted
no islet transplantation (for a non nephrologic reason)

Locations

Country	Name	City	State
France	Lille University Hospital	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	number of cardiovascular events		At 10 years
Secondary	number of deaths		At 10 years