Viewing Study NCT04355832


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Ignite Modification Date: 2025-12-25 @ 7:26 PM
Study NCT ID: NCT04355832
Status: WITHDRAWN
Last Update Posted: 2025-11-07
First Post: 2020-04-17
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Glucagon-like Peptide-1 in Type 1 Diabetes
Sponsor: University of Maryland, Baltimore
Organization:

Study Overview

Official Title: Reducing Hypoglycemic, Pro-coagulant and Pro-atherothrombotic Responses and Preventing Hypoglycemia Associated Autonomic Failure in Type 1 DM. The Effects of Glucagon-like Peptide-1
Status: WITHDRAWN
Status Verified Date: 2025-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: We were unable to obtain GLP-1
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The hypotheses to be tested in this application is: GLP-1 will acutely protect arterial endothelial function and reduce pro-atherothrombotic and pro-coagulant effects of repeated hypoglycemia in T1DM.
Detailed Description: The naturally occurring hormone GLP-1 when co-administered during hypoglycemia (low blood sugar) in non-diabetic individuals can reduce the deleterious effects of hypoglycemia on the vasculature. We have shown that IV infusion of GLP-1 during a single moderate episode of hypoglycemia can preserve endothelial function and protect the vasculature from pro-coagulant and pro-inflammatory effects in healthy individuals.

It is unknown whether GLP-1 could protect the vasculature during episodes of repeated hypoglycemia and whether GLP-1 would have protective effects in T1DM individuals.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: True
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?: