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Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

NCT02627690 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2022-04-29

No results posted yet for this study

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

Interventions

OTHER

islet transplanted

islet transplantation

OTHER

non islet transplanted

no islet transplantation (for a non nephrologic reason)

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Marie-Christine VANTYGHEM, MD, PhD · Lille University Hospital

Eligibility

Min Age
18 Years
Max Age
77 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-03
Primary Completion
2021-11-29
Completion
2021-11-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02627690 on ClinicalTrials.gov