protocolSection identificationModule nctId: NCT06338553, orgStudyIdInfo id: 231620, briefTitle: GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab, acronym: GLP-TEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Vanderbilt University Medical Center, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Type 1 Diabetes, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: In this study, participants with stage 2 T1DM undergoing Teplizumab (TZIELD®) treatment will be randomly assigned to receive single doses of either a GLP-1Ra or a placebo. Three separate MMTT tests will be conducted to assess the effects on blood sugar levels, insulin function, and vascular health. The first test will occur before TZIELD® treatment and participants will receive a placebo at this MMTT. The other two tests will take place 3-5 months after TZIELD® treatment. In these post-treatment tests, the study team will 'cross over', or switch, the order in which participants receive the GLP-1Ra or placebo, with a minimum one-week gap to avoid overlap of effects. For example, a participant may take the GLP-1Ra then placebo or the placebo then the GLP-1Ra. In some cases, the investigator may allow participants who have already received TZIELD® treatment prior to joining the study to skip the pre-treatment test and proceed directly to the post-treatment tests., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, maskingDescription: For applicable participants, a placebo will be given prior to a pre-TZIELD® meal test. For participants who have already received Teplizumab (TZIELD®) or those who are progressing to the 2 remaining study visits, a GLP-1Ra or placebo will be given in random orders at these two visits. The GLP-1Ra will only be given one time., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Semaglutide (Rybelsus®), outcomesModule primaryOutcomes measure: Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study, primaryOutcomes measure: Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study, primaryOutcomes measure: Determine the impact of GLP-1Ra on endothelial function in a pilot study, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Vanderbilt University Medical Center, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37232, country: United States, contacts name: Justin M Gregroy, MD, MSCI, role: CONTACT, phone: (615) 322- 7427, email: metabolism@vumc.org, contacts name: Tyler J Smith, DNP, APRN, FNP-C, role: CONTACT, email: metabolism@vumc.org, contacts name: Justin M Gregory, MD, MSCI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-12-27, uploadDate: 2024-03-01T16:04, filename: Prot_000.pdf, size: 567921, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-21, uploadDate: 2024-03-01T15:15, filename: ICF_001.pdf, size: 2385304, hasResults: False