Arginine Metabolism Study for Youth with Type 2 Diabetes
Trial Summary
Will I have to stop taking my current medications?
You may need to stop taking certain medications if they interfere with amino acid metabolism or if you are on hormonal replacement therapy. However, you can continue taking metformin, insulin, and liraglutide.
What data supports the effectiveness of the drug for youth with Type 2 Diabetes?
Is the use of stable isotopes, including L-arginine, safe in humans?
How is the Arginine Metabolism Study treatment different from other treatments for Type 2 Diabetes?
This treatment is unique because it uses a combination of intravenous arginine, oral glucose, and stable isotope infusion to study arginine metabolism, which is not a standard approach for managing Type 2 Diabetes. It focuses on understanding metabolic pathways rather than directly controlling blood sugar levels, which is the goal of most traditional diabetes treatments.910111213
What is the purpose of this trial?
Type 2 diabetes (T2D), once considered only "a disease of older ages," is now a significant public health concern in youth. Although it is characterized by insulin resistance and impaired insulin secretion, its precise etiology and pathogenesis are not yet fully understood. This study aims to (1) explore arginine metabolism in youth with T2D via safe, minimally invasive kinetic experiments using stable isotope tracers and targeted metabolomics, and (2) determine the effect of exogenous arginine administration on β-cell function in youth with T2D, potentially supporting the use of this safe, low-cost, and readily available nutrient to improve pediatric diabetes outcomes.
Research Team
Mustafa Tosur, MD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
This trial is for young people with Type 2 Diabetes, aged 12-20 years. Girls must be postmenarchal and boys at Tanner stage 5 genitalia. Participants should have been diagnosed with T2D for 3 months to 10 years. Those on hormonal therapy, insulin, or certain medications, or with other health issues like abnormal liver function or pregnancy cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Study Day 1
Participants receive a primed dose of stable isotopes followed by continuous intravenous infusions for 5 hours
Study Day 2
Participants undergo an oral glucose tolerance test after drinking a 75-gram glucose solution
Study Day 3
Participants undergo a modified oral glucose tolerance test with a 75-gram glucose solution and a 5-gram arginine injection
Follow-up
Participants are monitored for safety and effectiveness after the study procedures
Treatment Details
Interventions
- Intravenous arginine bolus
- Oral glucose ingestion
- Stable isotope infusion
Intravenous arginine bolus is already approved in United States, European Union for the following indications:
- Nutritional supplement
- Pharmaceutical aid
- Nutritional supplement
- Pharmaceutical aid
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator