Trial Information
Autologous Pancreatic Islet Cell Transplantation for Improved Glycaemic Control After Pancreatectomy: Observational Study
Inclusion Criteria:
- 18 years of age
- ability to provide written informed consent
- fasting glycaemia <126 mg/dl without glucose-lowering medications.
Exclusion Criteria:
- Any medical condition that, in the opinion of the investigator, will interfere with
the safe completion of the trial
- Diagnosis of intraductal papillary mucinous cancer, unless the absence of multifocal
lesion is demonstrated by endoscopic US
- Presence of multifocal or residual disease at the pancreatic margin. If a malignat
disease is the reason for the surgery, 1 cm of the pancreatic remnant in proximity to
the pancreatic margin will be resected and sent for immediate pathologic analysis to
confirm margin negativity and to rule out multifocal tumor
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Beta cell function
Outcome Description:
Beta-cell function will be assessed by fasting C peptide, HbA1c,glycaemia, change in average daily insulin requirements, basal (fasting) and -10 to 120 min time course of glucose, C-peptide and insulin derived from the arginine test, beta-score and Transplant Estimated Function
Outcome Time Frame:
month 1, 3, 6, 12 and every year up to death
Safety Issue:
No
Principal Investigator
Lorenzo Piemonti, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Scientific Institute San Raffaele
Authority:
Italy: Ministry of Health
Study ID:
43-09/02/2012
NCT ID:
NCT01702051
Start Date:
February 2012
Completion Date:
October 2018
Related Keywords:
- Diabetes
- Pancreatogenic diabetes
- Autologou Islet Transplantation
- Pancreas
- Pancreatectomy
- Diabetes Mellitus