nctId: NCT06338553 id: 231620 briefTitle: GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab acronym: GLP-TEP overallStatus: RECRUITING date: 2024-06 date: 2027-03 date: 2027-03 date: 2024-03-29 date: 2024-04-03 name: Vanderbilt University Medical Center class: OTHER 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. conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: EARLY_PHASE1 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 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 count: 24 type: ESTIMATED name: Placebo name: Semaglutide (Rybelsus®) measure: Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study measure: Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study measure: Determine the impact of GLP-1Ra on endothelial function in a pilot study sex: ALL minimumAge: 12 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Vanderbilt University Medical Center status: RECRUITING city: Nashville state: Tennessee zip: 37232 country: United States name: Justin M Gregroy, MD, MSCI role: CONTACT phone: (615) 322- 7427 email: metabolism@vumc.org name: Tyler J Smith, DNP, APRN, FNP-C role: CONTACT email: metabolism@vumc.org name: Justin M Gregory, MD, MSCI role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 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 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