Type 1 Diabetes Mellitus
Conditions
Brief summary
This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.
Detailed description
The main objective is to demonstrate the beneficial effect of islet allotransplantation in patients with type 1 diabetes with no endogenous insulin secretion, and with a functional kidney graft. The other objectives are to evaluate the conditions for the efficacy of islet cell transplantation, to assess the improvement in quality of life and the cost of the islet cell transplantation.
Interventions
human pancreatic islet transplantation
Sponsors
University Hospital, Grenoble
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus * Disease duration \> 5 years * ketose antecedents * Basal and stimulated plasma C-\< 0.2 ng/ml,\<0.06 nmol/l (glycemia must be measured simultaneously\_ 1.20 g/l or 6.6 mM, stimulation with glucagon IV 1 mg -Measured at à T0 and T 6 min) * Established kidney graft ≥ 6 months * Current creatinine clearance: ≥ 50 ml/min/1.73 m² and Proteinuria \< 0.5 g/24h * HbA1C\< 12%
Exclusion criteria
* Hemostasis problems * Documented hepatic pathology * Patient under 18 or over 65 year-old * Women with body weight over 70 kg (tolerance of 2 kg between inclusion day and transplantation day) or BMI \> 26 * Men with body weight \> 75 kg (tolerance of 3 kg between inclusion day and transplantation day) or BMI \> 26 * insuline needs \> 0.7 U/kg/j or 50 U/j * Serious life-threatening pathology * untreated hyperlipidemia * Hypersensitivity to drugs rapamycine-alike * Liver disease (transaminases or total bilirubin ≥ 3N) * Failure to communicate or cooperate with the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Tolerance (Measurement of portal pressure during islet injection) Quality of life (Questionnaires SF-36 and DQOL at inclusion time, then every 6 months during their waiting period and then 6 months and 12 months after transplantation) Costs | 12 months |
Countries
France, Switzerland
Outcome results
None listed