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OpenTrials
Completed

NCT Number: NCT02627690

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

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Key information

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lille University Hospital

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

islet transplanted

Other

islet transplantation

Other names: Islet transplantation

non islet transplanted

Other

no islet transplantation (for a non nephrologic reason)

Other names: no islet transplantation

Primary outcomes

  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 outcomes

  1. number of cardiovascular events

    Time frame: At 10 years

  2. number of deaths

    Time frame: At 10 years

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: PRONOCELDIAB

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2015
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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