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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
human pancreatic islet transplantation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital
  • University Hospital, Department of Endocrinology
  • University Hospital, Department of Endocrinology
  • University Hospital, Department of Endocrinology
  • University Hospital, Department of Endocrinology
  • University Hospital, Department of Endocrinology
  • University Hospital, Department of Surgery

Outcomes

Primary Outcome Measures

Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves

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

Full Information

First Posted
March 14, 2008
Last Updated
May 28, 2010
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT00639600
Brief Title
Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft
Acronym
GRAGIL1
Official Title
Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Terminated
Why Stopped
a new study has began recently
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
human pancreatic islet transplantation
Intervention Description
human pancreatic islet transplantation
Primary Outcome Measure Information:
Title
Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Y Benhamou, MD, PhD
Organizational Affiliation
University Hospital of Grenoble, Department of Endocrinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
University Hospital, Department of Endocrinology
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
University Hospital, Department of Endocrinology
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
University Hospital, Department of Endocrinology
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
University Hospital, Department of Endocrinology
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
University Hospital, Department of Endocrinology
City
Strasbourg
ZIP/Postal Code
66000
Country
France
Facility Name
University Hospital, Department of Surgery
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26068866
Citation
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.
Results Reference
derived

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

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