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Nephrologic Prognosis 10 Years After Diabetes Cell Therapy (PRONOCELDIAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02627690
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : July 3, 2019
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Islet Transplantation Other: islet transplanted Other: non islet transplanted

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Nephrologic Prognosis 10 Years After Diabetes Cell Therapy
Study Start Date : September 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Islet transplanted
patients who underwent islet transplantation
Other: islet transplanted
islet transplantation
Other Name: Islet transplantation

non islet transplanted
patients who refused or were non selected for islet transplantation for a non nephrologic reason
Other: non islet transplanted
no islet transplantation (for a non nephrologic reason)
Other Name: no islet transplantation

Primary Outcome Measures :
  1. Modification of Diet in Renal Disease (MDRD) [ Time Frame: 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 :
  1. number of cardiovascular events [ Time Frame: At 10 years ]
  2. number of deaths [ Time Frame: At 10 years ]

Biospecimen Retention:   Samples With DNA
serum and DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering of type 1 diabetes since at least 10 years

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02627690

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Contact: Marie-Christine MC VANTYGHEM, MD, PhD

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Lille University Hospital Recruiting
Lille, France, 59037
Contact: Marie Christin VANTYGHEM, MD PhD    +33 3 20 44 45 35   
Sponsors and Collaborators
University Hospital, Lille
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Principal Investigator: Marie-Christine VANTYGHEM, MD, PhD Lille University Hospital

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Responsible Party: University Hospital, Lille Identifier: NCT02627690     History of Changes
Other Study ID Numbers: 2013_28
2014-A00141-46 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No