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Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft (GRAGIL1)
This study is currently recruiting participants.
Verified by University Hospital, Grenoble, July 2003
Sponsored by: University Hospital, Grenoble
Information provided by: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00639600
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Procedure: human pancreatic islet transplantation
Phase I
Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1 Islet Cell Transplantation
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1.

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: July 2003
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: human pancreatic islet transplantation
    human pancreatic islet transplantation
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion criteria that are specific to the use of Rapamycine

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639600

Contacts
Contact: Pierre Y Benhamou + 33 476769349 PYBenhamou@chu-grenoble.fr

Locations
France
University Hospital, Department of Endocrinology Recruiting
Grenoble, France, 38043
Contact: Pierre Y Benhamou     + 33 476769349     PYBenhamou@chu-grenoble.fr    
Principal Investigator: Pierre Y Benhamou, MD, PhD, Pr            
Sub-Investigator: François Bayle, PhD            
Sub-Investigator: Jean L Descotes, Pr            
University Hospital, Department of Endocrinology Recruiting
Lyon, France, 69000
Sub-Investigator: Charles Thivolet, Pr            
Sub-Investigator: Emmanuel Morelon, Pr            
Sub-Investigator: Xavier Martin, Pr            
Sub-Investigator: Lionel Badet, Pr            
University Hospital Recruiting
Besancon, France, 25000
Sub-Investigator: Alfred Penfornis, Pr            
Sub-Investigator: Jean M Chalopin, Pr            
University Hospital, Department of Endocrinology Recruiting
Strasbourg, France, 66000
Sub-Investigator: Michel Pinget, Pr            
Sub-Investigator: Laurence Kessler, Pr            
Sub-Investigator: Bruno Moulin, Pr            
Sub-Investigator: Philippe Wolf, Pr            
University Hospital, Department of Endocrinology Recruiting
Nancy, France, 54000
Sub-Investigator: Luc Frimat, Pr            
Sub-Investigator: Bruno Guerci, Pr            
University Hospital, Department of Endocrinology Recruiting
Montpellier, France, 34000
Sub-Investigator: Eric Renard, Pr            
Sub-Investigator: Georges Mourad, Pr            
Switzerland
University Hospital, Department of Surgery Recruiting
Geneva, Switzerland, 1211
Sub-Investigator: Philippe Morel, Pr            
Sub-Investigator: Thierry Berney, PhD            
Sub-Investigator: Jacques Philippe, Pr            
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Pierre Y Benhamou, MD, PhD University Hospital of Grenoble, Department of Endocrinology
  More Information

Responsible Party: University Hospital, Grenoble ( Pierre-Yves Benhamou )
Study ID Numbers: 95/CHUG/10/C2
Study First Received: March 14, 2008
Last Updated: March 19, 2008
ClinicalTrials.gov Identifier: NCT00639600  
Health Authority: France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009