Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft
NCT ID: NCT00639600
Last Updated: 2010-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2008-06-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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human pancreatic islet transplantation
human pancreatic islet transplantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Hypercholesterolemia (\> 350mg/dl, 9,1 mmol/l) not controlled
* Hypertriglyceridemia (\> 500 mg/dl, 5,6 mmol/l) not controlled
* Leukocytes \> 4500 /mm3 , neutrophils \> 2000/ mm3, platelets \> 100000/ mm3
* Any clinical or biological pathology that could interfere with the study
* Past or present neoplasia (with the exception of non melanoma skin cancers)
* Any hemostasis disorder needing a prolonged treatment with anticoagulation drugs. Low-dose aspirin is permitted.
* Pregnancy, lactation, pregnancy project or absence of efficient contraception
* Any medical or psychosocial condition susceptible to interfere with the study, such as drug abuse or recent alcohol abuse
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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University Hospital, Grenoble
Principal Investigators
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Pierre Y Benhamou, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Grenoble, Department of Endocrinology
Locations
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University Hospital
Besançon, , France
University Hospital, Department of Endocrinology
Grenoble, , France
University Hospital, Department of Endocrinology
Lyon, , France
University Hospital, Department of Endocrinology
Montpellier, , France
University Hospital, Department of Endocrinology
Nancy, , France
University Hospital, Department of Endocrinology
Strasbourg, , France
University Hospital, Department of Surgery
Geneva, , Switzerland
Countries
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References
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Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tetaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.
Other Identifiers
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95/CHUG/10/C2
Identifier Type: -
Identifier Source: org_study_id