RecruitingEarly Phase 1NCT06338553

GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab

Optimizing Stage 2 T1DM Management: Assessing the Impact of GLP-1Ra on Metabolic Outcomes in Patients Receiving Teplizumab


Sponsor

Vanderbilt University Medical Center

Enrollment

24 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

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 different conditions and observing how their bodies respond, focusing on blood sugar levels, insulin effectiveness, and blood vessel function. The meal tests are 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.


Eligibility

Min Age: 12 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a GLP-1 receptor agonist medication (a drug commonly used for type 2 diabetes and weight loss) can improve metabolic health and slow the progression of type 1 diabetes in people who are at an early stage — either pre-clinical stage 2 (no symptoms yet) or newly diagnosed stage 3. Some participants also receive teplizumab (an immune-modifying drug that delays type 1 diabetes onset). **You may be eligible if...** - You are 12 to 50 years old - You have stage 2 type 1 diabetes (2 or more diabetes-related antibodies plus specific blood sugar test results) OR early stage 3 type 1 diabetes (newly diagnosed within 8 weeks, HbA1c 5.7%–8.0%) - Your BMI is within the study range (18–31 for adults, 5th–95th percentile for children) **You may NOT be eligible if...** - You have high blood pressure, reduced kidney function, or significant liver disease - You have a family history of medullary thyroid cancer - You have had pancreatitis or gastroparesis in the past 3 years - You are taking diabetes medications, steroids, antipsychotics, certain blood pressure drugs, or oral contraceptives with higher estrogen levels - You are pregnant, post-menopausal, or an active smoker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSemaglutide (Rybelsus®)

7 mg single dose of Rybelsus® by mouth once before each MMTT

DRUGPlacebo

placebo capsule or tablet once before each MMTT.


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06338553


Related Trials