Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338553
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-03-07
Brief Title:
GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Optimizing Stage 2 T1DM Management Assessing the Impact of GLP-1Ra on Metabolic Outcomes in Patients Receiving Teplizumab
Status:
RECRUITING
Status Verified Date:
2024-06
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:
GLP-TEP
Brief Summary:
The goal of this study is to determine how a drug class called glucagon-like peptide-1 receptor agonists GLP-1Ra affects people during an early stage of Type 1 Diabetes undergoing clinical teplizumab treatment This study involves giving participants a liquid meal under three different conditions and observing how their bodies respond focusing on blood sugar levels insulin effectiveness and blood vessel function The first meal test is pre-teplizumab followed by two post-treatment tests one with the GLP-1Ra drug and the other with a placebo Each test involves blood draws before and during the meal test GLP-1Ra or placebo administration and an ultrasound to measure blood vessel function The goal is to see if GLP-1Ra can help manage blood sugar levels and improve cardiovascular health in this population
Detailed Description:
The long-term goal is to determine whether repurposing GLP-1Ra for stage 2 T1DM in combination with immunotherapy can modify the disease course reducing the need for exogenous insulin therapy and leading to improved cardiometabolic outcomes and quality of life The immediate objective is to investigate the impact of GLP-1Ras insulinotropic and glucagonostatic effects on dysmetabolism in stage 2 T1DM patients treated with teplizumab The study hypothesizes that these effects will each delay the need for exogenous insulin by improving three key aspects of dysmetabolism 1 postprandial glycemia 2 disposition index ie the ability of the islet cells to compensate for a given insulin sensitivity and 3 endothelial function The rationale for this hypothesis is based on two observations first GLP-1Ra combined with immunomodulatory therapy sustains endogenous secretion in response to a mixed meal tolerance test MMTT during the first year of stage 3 and second GLP-1Ras mitigate postprandial hyperglucagonemia in longer-duration T1DM To test the hypothesis studies will be conduct in individuals with stage 2 T1DM treated with teplizumab using a crossover design structured around the following specific aims
Aim 1 Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study The study team will measure postprandial glycemia during an MMTT before teplizumab treatment After teplizumab the study team will compare the effects of placebo versus semaglutide a GLP-1Ra
Aim 2 Study the impact of GLP-1Ra on the disposition index DI in a pilot study The study team will use the oral glucose minimal model to measure DI during an MMTT before and after teplizumab treatment comparing the effects of placebo versus semaglutide As an exploratory outcome β-cell endoplasmic reticulum dysfunction will be quantified by measuring the proinsulin-to-C-peptide ratio during the MMTT
Aim 3 Determine the impact of GLP-1Ra on endothelial function in a pilot study The stud team will use B-mode ultrasound to measure flow mediated vasodilation FMD a bioassay of endothelial function during each MMTT Because endothelial cells are often among the first affected by hyperglycemia and insulin resistance the study aims to illuminate how GLP-1Ra may mitigate early vascular disease progression
Aim 1 Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study The study team will measure postprandial glycemia during an MMTT before teplizumab treatment After teplizumab the study team will compare the effects of placebo versus semaglutide a GLP-1Ra
Aim 2 Study the impact of GLP-1Ra on the disposition index DI in a pilot study The study team will use the oral glucose minimal model to measure DI during an MMTT before and after teplizumab treatment comparing the effects of placebo versus semaglutide As an exploratory outcome β-cell endoplasmic reticulum dysfunction will be quantified by measuring the proinsulin-to-C-peptide ratio during the MMTT
Aim 3 Determine the impact of GLP-1Ra on endothelial function in a pilot study The stud team will use B-mode ultrasound to measure flow mediated vasodilation FMD a bioassay of endothelial function during each MMTT Because endothelial cells are often among the first affected by hyperglycemia and insulin resistance the study aims to illuminate how GLP-1Ra may mitigate early vascular disease progression
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?:
False
Is an FDA AA801 Violation?:
None