Clinical trial NCT03067324: Quality Control of Pancreatic Islet Intended to Islet Graft Cells Intended to Stabilot Islet Graft Protocol
Official title: Quality Control of Pancreatic Islet Intended to Islet Graft
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Islet Quality Control
Keywords: Islet Transplantation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Hospital, Bordeaux
First posted: 2017-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP

Brief summary: Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.

Detailed description: Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.

The project aims to :

* develop the bio-sensor necessary to measure islet membrane electric potential
* develop interface between bio-sensor and user
* correlate analysis data collected by bio-sensor with metabolic results of islet graft

Eligibility criteria: Inclusion Criteria:

* Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP

Exclusion Criteria:

* Patients not enrolled in STABILOT Pancreatic Islet cell graft or patients that signed the form expressing their refuse to participate to ISLET CHIP.

Primary outcomes:
measure: Beta-score
timeFrame: 6 months in average before second islet graft
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Besançon University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont Ferrand University hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Lyon
country: France
facility: Lyon University Hospital
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nancy
country: France
facility: Nancy University hospital
city: Strasbourg
country: France
facility: University hospital of Strasbourg
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Sandrine LABLANCHE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Bogdan CATARGI, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Kusnik-Joinville O, Weill A, Salanave B, Ricordeau P, Allemand H. Prevalence and treatment of diabetes in France: trends between 2000 and 2005. Diabetes Metab. 2008 Jun;34(3):266-72. doi: 10.1016/j.diabet.2008.01.005. Epub 2008 Jun 3.
citation: Gruessner RW, Gruessner AC. The current state of pancreas transplantation. Nat Rev Endocrinol. 2013 Sep;9(9):555-62. doi: 10.1038/nrendo.2013.138. Epub 2013 Jul 30.
citation: Ricordi C, Lacy PE, Finke EH, Olack BJ, Scharp DW. Automated method for isolation of human pancreatic islets. Diabetes. 1988 Apr;37(4):413-20. doi: 10.2337/diab.37.4.413.
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.
citation: Lebreton F, Pirog A, Belouah I, Bosco D, Berney T, Meda P, Bornat Y, Catargi B, Renaud S, Raoux M, Lang J. Slow potentials encode intercellular coupling and insulin demand in pancreatic beta cells. Diabetologia. 2015 Jun;58(6):1291-9. doi: 10.1007/s00125-015-3558-z. Epub 2015 Mar 19.
citation: Renaud S, Catargi B, Lang J. Biosensors in diabetes : how to get the most out of evolution and transpose it into a signal. IEEE Pulse. 2014 May-Jun;5(3):30-4. doi: 10.1109/MPUL.2014.2309577.