GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab
Eligible age
12–50 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Vanderbilt University Medical Center
You may qualify if…
- ✓ Age: 12-50 years
- ✓ BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric)
- ✓ Stage 2 T1DM (i.e., ≥ 2 islet auto-antibodies and:
- ✓ fasting glucose ≥ 100 mg/dL and \< 126 mg/dL OR
- ✓ 2-hr OGTT /MMTT ≥ 140 mg/dL and \< 200 mg/dL OR
- ✓ During an OGTT having a glucose of \> 199 mg/dL at 30, 60, or 90 minutes)
You may not qualify if…
- ✕ Comorbidities:
- ✕ SBP \> 140 mmHg and DBP \> 100 mmHg
- ✕ eGFR by MDRD equation of \< 60 mL/min/1.73m2
- ✕ AST or ALT \> 2.5 times ULN
- ✕ Family history of medullary thyroid carcinoma
- ✕ Diagnosis of pancreatitis or gastroparesis within the past 3 years
- ✕ Medications: Any diabetes medication, any antioxidant vitamin supplement (\<2 weeks before a study), any systemic glucocorticoid, antipsychotic, atenolol, metoprolol, propranolol, niacin, any thiazide diuretic, any OCP with \> 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, antihypertensive, any antihyperlipidemic
- ✕ Other: pregnancy, peri- or post-menopausal women, active smoker
Where it's recruiting
Nashville
Source: ClinicalTrials.gov · NCT06338553 · last updated 2025-12-18