Impact of GLP-1Ra on Metabolic Outcomes in Early Stage Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of glucagon-like peptide-1 receptor agonists (GLP-1Ra) on individuals with stage 2 Type 1 Diabetes who are receiving teplizumab treatment. Participants will undergo liquid meal tests under different conditions to assess their blood sugar levels, insulin effectiveness, and blood vessel function. The study employs a crossover design, where participants will receive either the GLP-1Ra drug or a placebo, followed by various blood draws and ultrasound tests. The aim is to determine if GLP-1Ra can improve glycemic control and cardiovascular health in this population.

Why it matters

Who can join: the full rules

Aims 1-3: Stage 2 T1DM with TZIELD® and GLP-1Ra

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Aim 4: Early Stage 3 T1DM with GLP-1Ra Monotherapy Inclusion Criteria

* Age: 12-50 years
* BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric)
* Early stage 3 T1DM with either
* HbA1c 6.5% to 8.0% at diagnosis OR
* HbA1c 5.7% to 6.4% with oral glucose test meeting ADA criteria for stage 3 T1DM within the past three months prior to or during screening visit
* Time of stage 3 diagnosis: within eight weeks of first study visit

Exclusion Criteria

* DKA history: history of diabetic ketoacidosis requiring hospital admission
* Comorbidities:
* 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 running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Daniel J Moore, MD, PhD
• Email: metabolism@vumc.org
• Phone: (615) 322- 7427

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Next Generation Extended Wear Sensors in Type 1 and Type 2 Diabetes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.