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NCT05477134Completed

Arginine Metabolism in Youth With Type 2 Diabetes

Arginine Metabolism in Pediatric Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 13 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (actual)
First submitted
25 Jul 2022
Start date
6 Feb 2023
Primary completion date
18 Jun 2026
Lead sponsor
Baylor College of Medicine
NCT number
NCT05477134

What you commit to

  • Study type: Interventional
  • Participants enrolled: 30
  • From 6 Feb 2023 to the primary completion date, 18 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous history of diabetic ketoacidosis (DKA)

Lab values

  • Poorly controlled diabetes defined as HbA1c \>7.5%,
  • Renal insufficiency defined by eGFR (estimated glomerular filtration rate) \<90 mL/min/1.73 m2,
  • 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.

Other

  • Abnormal liver, thyroid, gonadal or adrenal functions,

Who the study is looking for

  • Youth with type 2 diabetes and healthy controls who meet other inclusion criteria outlined below.
  • 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),
  • Additional criteria for youth with diabetes: i. diagnosis of T2D, and ii. diabetes duration between 3 months and 10 years.

Age in the registry: 12 years to 20 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Texas Children's Hospital/ Baylor College of Medicine
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.