Exploring arginine metabolism in youth with type 2 diabetes
Arginine Metabolism in Pediatric Type 2 Diabetes
This study is testing how arginine affects insulin and diabetes management in young people with type 2 diabetes to see if giving extra arginine can help improve their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years to 20 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05477134 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of arginine metabolism in youth with type 2 diabetes (T2D) through minimally invasive experiments using stable isotope tracers and targeted metabolomics. It aims to understand how arginine affects insulin secretion and β-cell function in this population. The study will also assess the impact of administering exogenous arginine on improving diabetes outcomes in youth. By focusing on a demographic that has seen a significant rise in T2D cases, the research seeks to uncover potential therapeutic avenues for managing this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are youth aged 12 to 20 with a diagnosis of type 2 diabetes and specific inclusion criteria.
Not a fit: Patients with poorly controlled diabetes, a history of diabetic ketoacidosis, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective nutritional intervention to improve insulin secretion and overall diabetes management in youth.
How similar studies have performed: While studies in adults have shown promising results regarding arginine's effects on insulin secretion, this specific approach in youth with T2D is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Youth with type 2 diabetes and healthy controls who meet other inclusion criteria outlined below. 2. Age and pubertal stage criteria (12- to 20-year-old girls who are postmenarchal, and 14- to 20-year-old boys who are at Tanner stage 5 genitalia), 3. Additional criteria for youth with diabetes: i. diagnosis of T2D, and ii. diabetes duration between 3 months and 10 years. Exclusion Criteria: 1. Previous history of diabetic ketoacidosis (DKA) 2. Poorly controlled diabetes defined as HbA1c \>7.5%, 3. Abnormal liver, thyroid, gonadal or adrenal functions, 4. Renal insufficiency defined by eGFR (estimated glomerular filtration rate) \<90 mL/min/1.73 m2, 5. Any glucose lowering medications except metformin, insulin and liraglutide (7) Any medication use that will likely to interfere amino acid metabolism, (8) Any hormonal replacement therapy, and (9) Pregnancy.
Where this trial is running
Houston, Texas
- Texas Children's Hospital / Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Mustafa Tosur, MD — Baylor College of Medicine
- Study coordinator: Mustafa Tosur, MD
- Email: mustafa.tosur@bcm.edu
- Phone: 832-822-3780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.