Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455319
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-03
Brief Title:
Precision Administration of Anti-thymocyte Globulin With or Without Verapamil
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Precision Administration of Anti-thymocyte Globulin With or Without Verapamil in Adolescents and Young Adults With Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
T cell directed therapy anti-thymocyte globulin ATG in low doses has been shown to lower HbA1c and preserve endogenous insulin production measured by C-peptide in individuals with recently diagnosed type 1 diabetes T1D However not all individuals who received ATG responded to the therapy ie non-responders Additionally use of ATG alone does not address inherent beta cell stress A calcium channel blocker verapamil has demonstrated C-peptide preservation in newly diagnosed T1D Investigators will identify those mostly likely to respond to ATG using an ex vivo predictive biomarker of response to ATG In addition Investigators will use sequential therapies to increase efficacy ATG followed by verapamil and explore synergistic mechanisms This will be assessing with in depth immunophenotyping and quantify biomarkers of beta cell stress cell death and abnormal prohormone processing Finally novel clinical trial endpoints will be assessed for their ability to predict treatment efficacy earlier than the standard endpoint at 1 year
Detailed Description:
Investigators will conduct a phase 2 11 randomized controlled and blinded trial in Aim 1 comparing stimulated C-peptide and other measures between those treated with low-dose ATG and those treated with placebo Co-primary endpoints include the difference between mean ATG and placebo values of the 2-hr mixed meal tolerance test MMTT-stimulated area under the curve AUC C-peptide at 12 months standard T1D trial measure and the difference between the change in the same measure over the first 6 months Participants will be stratified based on their ex vivo immune responder signature to allow an equal number of responders and non-responders in both treatment arms Following each participants completion of this 1 year randomized controlled trial RCT they will enter Aim 2 and be re-randomized to received verapamil or not in an open-label 1 year extension where mechanistic endpoints will be explored related to immunophenotyping gene expression DNA methylation and beta cell markers including markers of beta cell stress and death as well as markers of abnormal prohormone processing
Study Oversight
Has Oversight DMC:
None
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?:
None