Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft (GRAGIL1)

This study has been terminated.
(a new study has began recently)
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00639600
First received: March 14, 2008
Last updated: May 28, 2010
Last verified: May 2010
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1

Resource links provided by NLM:


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: June 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639600

Locations
France
University Hospital
Besancon, France, 25000
University Hospital, Department of Endocrinology
Grenoble, France, 38043
University Hospital, Department of Endocrinology
Lyon, France, 69000
University Hospital, Department of Endocrinology
Montpellier, France, 34000
University Hospital, Department of Endocrinology
Nancy, France, 54000
University Hospital, Department of Endocrinology
Strasbourg, France, 66000
Switzerland
University Hospital, Department of Surgery
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Pierre Y Benhamou, MD, PhD University Hospital of Grenoble, Department of Endocrinology
  More Information

No publications provided

Responsible Party: Pierre-Yves Benhamou, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00639600     History of Changes
Other Study ID Numbers: 95/CHUG/10/C2
Study First Received: March 14, 2008
Last Updated: May 28, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014