Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733508
Status:
UNKNOWN
Last Update Posted:
2021-02-02
First Post:
2020-10-08
Brief Title:
Glucagon Like Peptide 1 Receptor GLP1R Expression and Beta-cell Mass in Patients With Type 2 Diabetes
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Glucagon Like Peptide 1 Receptor GLP1R Expression and Beta-cell Mass in Patients With Type 2 Diabetes - the Role of Glucose Homeostasis on Uptake of Beta-cell Tracer Exendin-4
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
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:
GLP1R-T2D
Brief Summary:
Validation of the exendin-based beta cell imaging technique in patients with type 2 diabetes
Detailed Description:
Rationale Reliable imaging biomarkers for non-invasive characterisation of beta-cell mass BCM are needed to aid understanding regarding the relationship between beta-cell mass and function during the course of type 2 diabetes T2D This study will provide critical information necessary to validate the applicability of exendin-based imaging techniques in patients with T2D The characterization of beta-cells is currently limited to pancreatic specimens available at autopsy as in vivo pancreatic biopsy is associated with complications unacceptable in clinical studies To date only measurements of circulating C-peptide and insulin levels can be obtained but these measures do not reflect beta-cell mass only total beta-cell function Reliable imaging biomarkers for non-invasive characterisation of beta cell mass are therefore needed These biomarkers could also be used to validate novel therapeutic strategies aimed to increase or preserve BCM or identify whether patients are eligible for a certain therapeutic strategy eg when certain amount of beta-cells is required One can also think of identifying early responders to therapies to avoid unnecessary drug use and the accompanying costs
The objective of this study is to determine the specificity of Exendin-4 during the course of T2D and to examine the role of glycemic control on the correlation between pancreatic Exendin-4 uptake BCM and GLP-1R expression in patients with T2D undergoing partial pancreatectomy This will allow examination of the role of glycemic control on exendin uptake in humans but also implementation of clinical guidelines for the interpretation of clinical exendin-based scans in patients with T2D to avoid false interpretation of the scans
The objective of this study is to determine the specificity of Exendin-4 during the course of T2D and to examine the role of glycemic control on the correlation between pancreatic Exendin-4 uptake BCM and GLP-1R expression in patients with T2D undergoing partial pancreatectomy This will allow examination of the role of glycemic control on exendin uptake in humans but also implementation of clinical guidelines for the interpretation of clinical exendin-based scans in patients with T2D to avoid false interpretation of the scans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None