RECRUITING

Arginine Metabolism in Youth With Type 2 Diabetes

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

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.

Official Title

Arginine Metabolism in Pediatric Type 2 Diabetes

Quick Facts

Study Start:2023-02-06
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05477134

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 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Youth with type 2 diabetes and healthy controls who meet other inclusion criteria outlined below.
  2. 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. 3. Additional criteria for youth with diabetes: i. diagnosis of T2D, and ii. diabetes duration between 3 months and 10 years.
  1. 1. Previous history of diabetic ketoacidosis (DKA)
  2. 2. Current use of exogenous insulin,
  3. 3. Poorly controlled diabetes defined as HbA1c \>8%,
  4. 4. Abnormal liver, thyroid, gonadal or adrenal functions,
  5. 5. Renal insufficiency defined by eGFR (estimated glomerular filtration rate) \<90 mL/min/1.73 m2,
  6. 6. Any glucose lowering medications except metformin,
  7. 7. Any medication use that will likely to interfere amino acid metabolism,
  8. 8. Any hormonal replacement therapy, and
  9. 9. Pregnancy.

Contacts and Locations

Study Contact

Mustafa Tosur, MD
CONTACT
832-822-3780
mustafa.tosur@bcm.edu
Lori Malone
CONTACT
832-822-3784
lmalone@bcm.edu

Principal Investigator

Mustafa Tosur, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Texas Children's Hospital / Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Mustafa Tosur, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

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 Date2023-02-06
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-02-06
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • Children
  • Pediatric type 2 diabetes
  • Pediatric diabetes
  • Arginine
  • Youth

Additional Relevant MeSH Terms

  • Type 2 Diabetes