Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

NCT02627690 | Completed

• 2 other identifiers: 2013_282014-A00141-46
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• number of cardiovascular events

  At 10 years

• number of deaths

  At 10 years

Study Arms (2)

Islet transplanted

patients who underwent islet transplantation

Other: islet transplanted

non islet transplanted

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

Other: non islet transplanted

Interventions

islet transplanted OTHER

islet transplantation

Also known as: Islet transplantation

Islet transplanted

non islet transplanted OTHER

no islet transplantation (for a non nephrologic reason)

Also known as: no islet transplantation

non islet transplanted

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering of type 1 diabetes since at least 10 years

You may qualify if:

• Who either benefit of islet transplantation or did not and treated with optimized insulin therapy

You may not qualify if:

• C-peptide positive diabetes
• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Lille University Hospital

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum and DNA

MeSH Terms

Interventions

Islets of Langerhans Transplantation

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Endocrine Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Marie-Christine VANTYGHEM, MD, PhD

  Lille University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: December 11, 2015
• Study Start: November 3, 2014
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)