Status:
COMPLETED
Trial Comparing Metabolic Efficiency of Islet Graft to Intensive Insulin Therapy for Type 1 Diabetes's Treatment
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
Efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin therapy for 2 categories of patients: patients with unstable diabetes and patients who underwent kidney transp...
Detailed Description
Efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin therapy for 2 categories of patients: patients with unstable type 1 diabetes versus patients with unstable typ...
Eligibility Criteria
Inclusion
- Patient with type 1 diabetes or C-peptide negative diabetes Diabetes duration \> 5 years
- 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
- Age\< 18 and \> 65
- 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
- Exclusion criteria non-specifically related to islet infusion: evolutive vascular disease, evolutive cardiopathy (especially myocardial infarction less than 6 months ago, cerebrovascular stroke less than 6 months ago, evolutive arteritis with trophic disorders) ; systemic infection including hepatitis C and HIV ; leuconeutropenia ; thrombocytopenia, non-stabilized neoplastic pathology ; pregnancy or project of pregnancy within the next 24 months ; poor therapeutic compliance
- 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)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01148680
Start Date
June 1 2010
End Date
September 1 2018
Last Update
January 27 2020
Active Locations (9)
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1
University Hospital, Department of Endocrinology
Strasbourg, Alsace, France, 67000
2
University Hospital, Department of Endocrinology
Grenoble, Auvergne-Rhône-Alpes, France, 38000
3
HCL Sud, Department of Endocrinology
Lyon, Auvergne-Rhône-Alpes, France, 69000
4
University Hospital Gabriel Montpied, Department of Endocrinology
Clermont-Ferrand, Auvergne, France, 63003