RECRUITING

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

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Conditions

Type 1 DiabetesStage 2 Type 1 DiabetesEarly Stage Type 1 DiabetesGLP1-RaRybelsusmixed meal tolerance test (MMTT)Stage 3 Type 1 Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-12
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06338553

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.

Ages Eligible for Study:12 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 12-50 years
  2. * BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric)
  3. * Stage 2 T1DM (i.e., ≥ 2 islet auto-antibodies and:
  4. * fasting glucose ≥ 100 mg/dL and \< 126 mg/dL OR
  5. * 2-hr OGTT /MMTT ≥ 140 mg/dL and \< 200 mg/dL OR
  6. * During an OGTT having a glucose of \> 199 mg/dL at 30, 60, or 90 minutes)
  1. * Comorbidities:
  2. * SBP \> 140 mmHg and DBP \> 100 mmHg
  3. * eGFR by MDRD equation of \< 60 mL/min/1.73m2
  4. * AST or ALT \> 2.5 times ULN
  5. * Family history of medullary thyroid carcinoma
  6. * Diagnosis of pancreatitis or gastroparesis within the past 3 years
  7. * 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
  8. * Other: pregnancy, peri- or post-menopausal women, active smoker
  9. * Age: 12-50 years
  10. * BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric)
  11. * Early stage 3 T1DM with either
  12. * HbA1c 6.5% to 8.0% at diagnosis OR
  13. * 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
  14. * Time of stage 3 diagnosis: within eight weeks of first study visit
  15. * DKA history: history of diabetic ketoacidosis requiring hospital admission
  16. * Comorbidities:
  17. * Family history of medullary thyroid carcinoma
  18. * Diagnosis of pancreatitis or gastroparesis within the past 3 years
  19. * 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
  20. * Other: pregnancy, peri- or post-menopausal women, active smoker

Contacts and Locations

Study Contact

Justin M Gregroy, MD, MSCI
CONTACT
(615) 322- 7427
metabolism@vumc.org
Wendi Welch, CCRP
CONTACT
metabolism@vumc.org

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-12
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-06-12
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Type 1 Diabetes
  • Stage 2 Type 1 Diabetes
  • Early Stage Type 1 Diabetes
  • GLP1-Ra
  • Rybelsus
  • mixed meal tolerance test (MMTT)
  • Stage 3 Type 1 Diabetes

Additional Relevant MeSH Terms

  • Type 1 Diabetes