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Clinical Trial Details

Trial ID: L7211
Source ID: NCT06338553
Associated Drug: Placebo
Title: GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab
Acronym: GLP-TEP
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Placebo|DRUG: Semaglutide (Rybelsus®)
Outcome Measures: Primary: Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study, Researchers will measure postprandial glycemia during an MMTT before TZIELD® treatment. After TZIELD®, the effects of placebo versus semaglutide (Rybelsus®),a GLP-1Ra, will be compared., During the MMTT in which the participant is randomly selected to receive semaglutide (Rybelsus®), glucose level will be checked at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 minutes|Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study, Researchers will use the oral glucose minimal model to measure DI during an MMTT before and after TZIELD® treatment, comparing the effects of placebo versus Rybelsus®. As an exploratory outcome, β-cell endoplasmic reticulum dysfunction will be determined by measuring the proinsulin-to-C-peptide ratio during the MMTT., Based on the glucose and insulin readings obtained at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 min and calculated approximately 1 month following completion of the MMTT once insulin levels in plasma are resulted.|Determine the impact of GLP-1Ra on endothelial function in a pilot study, B-mode ultrasound will be used 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, researchers aim to illuminate how GLP-1Ra may mitigate early vascular disease progression., During the last 30 minutes of each MMTT, between the 210 and 240 timepoints |
Sponsor/Collaborators: Sponsor: Vanderbilt University Medical Center
Gender: ALL
Age: CHILD, ADULT
Phases: EARLY_PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-12
Completion Date: 2027-03
Results First Posted:
Last Update Posted: 2024-06-21
Locations: Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
URL: https://clinicaltrials.gov/show/NCT06338553