Arginine Metabolism in Pediatric Type 2 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 20
Healthy Volunteers: t
View:

• 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.

Locations
United States
Texas
Texas Children's Hospital / Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Mustafa Tosur, MD
mustafa.tosur@bcm.edu
832-822-3780
Backup
Lori Malone
lmalone@bcm.edu
832-822-3784
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 30
Treatments
Experimental: The study cohort consisting of youth with type 2 diabetes and healthy controls
In Study Day 1, participants will be given a primed dose of stable isotopes followed by continuous intravenous infusions for 5 hours. The investigators will use the following isotopes: U-13C6-Arg, 5,5-2H2-Cit, 15N2-Orn, 2H5-Phe, and Na13CO3.~On Study Day 2, participants will drink a 75-gram glucose solution prior to an oral glucose tolerance test.~On Study Day 3, participants will drink a 75-gram glucose solution and will be injected 5-gram arginine into their veins.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov