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

Description

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.

Conditions

Type 1 Diabetes

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Type 1 Diabetes
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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
  • * 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
  • * 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

Ages Eligible for Study

12 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Study Record Dates

2027-03