Ignite Creation Date:
2024-05-06 @ 2:58 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02175459
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2014-06-23
Brief Title:
Investigating Predictive Factors of Diabetes Occurence After Duodenalpancreatectomy
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
None
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Regeneration of mature cells that produce functional insulin represents a major focus of current diabetes research aimed at restoring beta cell mass in patients with most forms of diabetes The capacity to adapt in response to diverse physiological conditions during life and the consequent ability to cope for increased metabolic demands is a distinctive feature of the endocrine pancreas in the regulation of glucose homeostasis Both beta and alpha cells are dynamically regulated to continually maintain a balance between proliferation neogenesis and apoptosis In this proposal the investigators will focus on exploring key mechanisms that potentially regulate islet cell plasticity in altered glucose metabolic states
Investigators will explore in a unique cohort of individuals who undergo duodenal pancretectomy Prior to their surgery will be performed in vivo studies Hyperglycemic clamp Euglycemic Hyperinsulinemic clamp and Mixed Meal Tests to accurately assess glucose homeostasis parameters to classify each individual into metabolic phenotypes Then exploit the opportunity to collect pancreas samples from these patients who will be evaluated again after surgery the investigators will determine the ability of the remnant pancreas to compensate for the acute reduction in islet mass and perform correlations between ex vivo and in vivo parameters
Specifically the patients will be subjected to incretin secretion mixed meal metabolic status OGTT insulin secretion characteristics first and second phase responses β-cell insulin content evaluation arginine bolus Subsequently pancreas samples will be evaluated for morphometry and proteomics and gene expression analyses of islet cell samples obtain by laser capture will allow a detailed investigation of mechanisms that contribute to islet plasticity The overall goal of this project is to investigate key mechanisms driving the ability of islet mass to adapt to diverse metabolic states We aim to explore modifications in gene expression and proteomics and correlate them with specific metabolic phenotypes in order to determine key regulators of islet morphology
Investigators will explore in a unique cohort of individuals who undergo duodenal pancretectomy Prior to their surgery will be performed in vivo studies Hyperglycemic clamp Euglycemic Hyperinsulinemic clamp and Mixed Meal Tests to accurately assess glucose homeostasis parameters to classify each individual into metabolic phenotypes Then exploit the opportunity to collect pancreas samples from these patients who will be evaluated again after surgery the investigators will determine the ability of the remnant pancreas to compensate for the acute reduction in islet mass and perform correlations between ex vivo and in vivo parameters
Specifically the patients will be subjected to incretin secretion mixed meal metabolic status OGTT insulin secretion characteristics first and second phase responses β-cell insulin content evaluation arginine bolus Subsequently pancreas samples will be evaluated for morphometry and proteomics and gene expression analyses of islet cell samples obtain by laser capture will allow a detailed investigation of mechanisms that contribute to islet plasticity The overall goal of this project is to investigate key mechanisms driving the ability of islet mass to adapt to diverse metabolic states We aim to explore modifications in gene expression and proteomics and correlate them with specific metabolic phenotypes in order to determine key regulators of islet morphology
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None