Trial Comparing Metabolic Efficiency of Islet Graft to Intensive Insulin Therapy for Type 1 Diabetes's Treatment
NCT ID: NCT01148680
Last Updated: 2020-01-27
Study Results
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Basic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2010-06-30
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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immediate registration on islet graft list
group 1 'immediate registration on infusion waiting list' : patients who will be immediately registrated on islet cell infusion waiting list after randomization.
Intervention : Procedure/surgery (islet graft)
Islet Graft
Iterative injection of pancreatic islets (minimum: 250,000 IEQ / injection or 3500 IEQ / kg / injection) with a threshold required total of 11,000 IEQ / kg in 2 or 3 injections per patient)
delayed registration on islet graft list
group 2 'delayed registration on infusion waiting list' : patients who will be registrated 6 months later on islet cell infusion waiting list after randomization.
Intervention : Procedure/surgery (islet graft)
Islet Graft
Iterative injection of pancreatic islets (minimum: 250,000 IEQ / injection or 3500 IEQ / kg / injection) with a threshold required total of 11,000 IEQ / kg in 2 or 3 injections per patient)
Interventions
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Islet Graft
Iterative injection of pancreatic islets (minimum: 250,000 IEQ / injection or 3500 IEQ / kg / injection) with a threshold required total of 11,000 IEQ / kg in 2 or 3 injections per patient)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No residual insulin secretion (plasmatic basal and stimulated C-peptide \< 0.3 ng/ml)
* HbA1c considered acceptable by the selection committee
* Insulin needs \< 0.85 IU/kg/day
* Islet cell infusion after kidney graft
* Patient with terminal renal failure and functional kidney graft for at least 6 months (creatinine clearance greater than or equal to 35 ml/min)
* Patient whose glycaemic control obtained with insulin therapy could threaten kidney graft survival and/or significantly alter quality of life. This situation is assessed by a diabetologist
* Islet cell infusion only: patient with major glycaemic variability despite proper intensive insulin therapy, closely monitored by a diabetologist. Poor glucose control, assessed by a diabetologist, endangers the patient's life and/or significantly alters personal, social, professional and family quality of life. At least one of these criteria must be fulfilled :
* Hypoglycaemia unawareness, blood glucose level \< 3mmol/L or 0.54 mg/L
* At least 2 severe hypoglycaemia events (defined by the necessity of a third party's assistance) per year or a ketoacidosis requiring patient's hospitalization during the last year.
* Impairment of quality of life or life-threat for patient or other persons, or progressive complications despite optimal insulin therapy
* Social Security membership or benefit from Social Welfare
Exclusion Criteria
* Diabetes duration \< 5 years
* Criteria specifically related to the islet intraportal injection procedure: hemostasis problem, haemoglobin level \< 11g/dL for women and \<12g/dL for men, abnormalities of complete blood count, documented liver pathology (alkaline phosphatases, gamma GT, transaminases levels over twice normal values) ; pancreatitis history, gallbladder stones that could potentially migrate; HLA hyperimmunisation (PRA \>20%).
* Criteria related to diabetes complications :
* Non-stabilized proliferating diabetic retinopathy
* Creatininaemia \> 16 mg/dL
* Criteria related to immunosuppressive protocol : renal failure (glomerular filtration \< 35 ml/min/1.73 m²) and/or proteinuria \> 0.5 g/24h ; non-treated hyperlipidemia (LDL-C \> 130 mg/dL) ; blood pressure \> 160/100 mmHg
* Clinical insulin resistance : assessed by patient's weight, BMI and exogenous insulin requirements (BMI \> 30 kg/m² or insulin dose \> 0.85 UI/kg/day)
18 Years
64 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Pierre-Yves Benhamou, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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University Hospital, Department of Endocrinology
Strasbourg, Alsace, France
University Hospital, Department of Endocrinology
Grenoble, Auvergne-Rhône-Alpes, France
HCL Sud, Department of Endocrinology
Lyon, Auvergne-Rhône-Alpes, France
University Hospital Gabriel Montpied, Department of Endocrinology
Clermont-Ferrand, Auvergne, France
University Hospital Besançon, Department of Endocrinology
Besançon, Franche-Comté, France
University Hospital, Department of General Surgery and Endocrinology
Lille, Hauts-de-France, France
University Hospital, Department of Endocrinology
Montpellier, Languedoc-Roussillon, France
University Hospital, Department of Endocrinology
Nancy, Lorraine, France
Hopitaux Universitaires de Genève, Department of Visceral Surgery and Transplant
Geneva, , Switzerland
Countries
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References
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Alejandro R, Barton FB, Hering BJ, Wease S; Collaborative Islet Transplant Registry Investigators. 2008 Update from the Collaborative Islet Transplant Registry. Transplantation. 2008 Dec 27;86(12):1783-8. doi: 10.1097/TP.0b013e3181913f6a.
Shapiro AM, Ricordi C, Hering BJ, Auchincloss H, Lindblad R, Robertson RP, Secchi A, Brendel MD, Berney T, Brennan DC, Cagliero E, Alejandro R, Ryan EA, DiMercurio B, Morel P, Polonsky KS, Reems JA, Bretzel RG, Bertuzzi F, Froud T, Kandaswamy R, Sutherland DE, Eisenbarth G, Segal M, Preiksaitis J, Korbutt GS, Barton FB, Viviano L, Seyfert-Margolis V, Bluestone J, Lakey JR. International trial of the Edmonton protocol for islet transplantation. N Engl J Med. 2006 Sep 28;355(13):1318-30. doi: 10.1056/NEJMoa061267.
Badet L, Benhamou PY, Wojtusciszyn A, Baertschiger R, Milliat-Guittard L, Kessler L, Penfornis A, Thivolet C, Renard E, Bosco D, Morel P, Morelon E, Bayle F, Colin C, Berney T; GRAGIL Group. Expectations and strategies regarding islet transplantation: metabolic data from the GRAGIL 2 trial. Transplantation. 2007 Jul 15;84(1):89-96. doi: 10.1097/01.tp.0000268511.64428.d8.
Vantyghem MC, Kerr-Conte J, Arnalsteen L, Sergent G, Defrance F, Gmyr V, Declerck N, Raverdy V, Vandewalle B, Pigny P, Noel C, Pattou F. Primary graft function, metabolic control, and graft survival after islet transplantation. Diabetes Care. 2009 Aug;32(8):1473-8. doi: 10.2337/dc08-1685.
Ryan EA, Paty BW, Senior PA, Lakey JR, Bigam D, Shapiro AM. Beta-score: an assessment of beta-cell function after islet transplantation. Diabetes Care. 2005 Feb;28(2):343-7. doi: 10.2337/diacare.28.2.343.
Bahougne T, Olagne J, Munch M, Braun-Parvez L, Chenard MP, Fremeaux-Bacchi V, Caillard S, Baltzinger P, Greget M, Kessler L, Moulin B. Atypical hemolytic and uremic syndrome due to C3 mutation in pancreatic islet transplantation: a case report. BMC Nephrol. 2020 Sep 19;21(1):405. doi: 10.1186/s12882-020-02062-7.
Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
Lablanche S, Vantyghem MC, Kessler L, Wojtusciszyn A, Borot S, Thivolet C, Girerd S, Bosco D, Bosson JL, Colin C, Tetaz R, Logerot S, Kerr-Conte J, Renard E, Penfornis A, Morelon E, Buron F, Skaare K, Grguric G, Camillo-Brault C, Egelhofer H, Benomar K, Badet L, Berney T, Pattou F, Benhamou PY; TRIMECO trial investigators. Islet transplantation versus insulin therapy in patients with type 1 diabetes with severe hypoglycaemia or poorly controlled glycaemia after kidney transplantation (TRIMECO): a multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2018 Jul;6(7):527-537. doi: 10.1016/S2213-8587(18)30078-0. Epub 2018 May 15.
Other Identifiers
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DCIC 08 31
Identifier Type: -
Identifier Source: org_study_id
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