NCT00639600

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2008

Geographic Reach
2 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 31, 2010

Status Verified

May 1, 2010

Enrollment Period

1.9 years

First QC Date

March 14, 2008

Last Update Submit

May 28, 2010

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (1)

  • 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

Interventions

human pancreatic islet transplantationPROCEDURE

human pancreatic islet transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Hemostasis problems
  • Documented hepatic pathology
  • Patient under 18 or over 65 year-old
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University Hospital

Besançon, 25000, France

Location

University Hospital, Department of Endocrinology

Grenoble, 38043, France

Location

University Hospital, Department of Endocrinology

Lyon, 69000, France

Location

University Hospital, Department of Endocrinology

Montpellier, 34000, France

Location

University Hospital, Department of Endocrinology

Nancy, 54000, France

Location

University Hospital, Department of Endocrinology

Strasbourg, 66000, France

Location

University Hospital, Department of Surgery

Geneva, 1211, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 26068866DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Pierre Y Benhamou, MD, PhD

    University Hospital of Grenoble, Department of Endocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2008

First Posted

March 20, 2008

Study Start

June 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 31, 2010

Record last verified: 2010-05

Locations

FR(6)CH(1)