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Nephrologic Prognosis 10 Years After Diabetes Cell Therapy (PRONOCELDIAB)

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ClinicalTrials.gov Identifier: NCT02627690
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

February 5, 2015
December 11, 2015
May 17, 2018
September 2014
December 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02627690 on ClinicalTrials.gov Archive Site
  • number of cardiovascular events [ Time Frame: At 10 years ]
  • number of deaths [ Time Frame: At 10 years ]
Same as current
Not Provided
Not Provided
 
Nephrologic Prognosis 10 Years After Diabetes Cell Therapy
Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

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

Not Provided
Observational
Observational Model: Case-Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
serum and DNA
Non-Probability Sample
Patients suffering of type 1 diabetes since at least 10 years
Islet Transplantation
  • Other: islet transplanted
    islet transplantation
    Other Name: Islet transplantation
  • Other: non islet transplanted
    no islet transplantation (for a non nephrologic reason)
    Other Name: no islet transplantation
  • Islet transplanted
    patients who underwent islet transplantation
    Intervention: Other: islet transplanted
  • non islet transplanted
    patients who refused or were non selected for islet transplantation for a non nephrologic reason
    Intervention: Other: non islet transplanted
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Same as current
December 2019
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact: Marie-Christine MC VANTYGHEM, MD, PhD marie-christine.vantyghem@chru-lille.fr
France
 
 
NCT02627690
2013_28
2014-A00141-46 ( Other Identifier: ID-RCB number, ANSM )
No
Not Provided
Plan to Share IPD: No
University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Marie-Christine VANTYGHEM, MD, PhD Lille University Hospital
University Hospital, Lille
May 2018