Lille University Hospital
Lille, 59037, France
NCT Number: NCT02627690
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
Looking for future studies?
Notify Me18 year–77 year
All sexes
Observational
Lille, 59037, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
islet transplantation
Other names: Islet transplantation
no islet transplantation (for a non nephrologic reason)
Other names: no islet transplantation
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.
Time frame: At 10 years
Time frame: At 10 years
University Hospital, Lille
Other
Acronym: PRONOCELDIAB
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.
Published trials that share one or more normalized conditions with this study.
NCT03427931
Autoimmune Diseases, Diabetes Mellitus
Charlottesville, Virginia, United States
View Trial DetailsNCT01369082
Autoimmune Diseases, Diabetes Mellitus
San Francisco, California, United States
View Trial DetailsNCT00417131
Autoimmune Diseases, Cardiovascular Diseases
Stockholm, Sweden
View Trial DetailsNCT05973734
Islet Transplantation
Palo Alto, California, United States
View Trial Details