Arginine Metabolism in Youth With Type 2 Diabetes

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05477134
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 20 Years
Healthy Volunteers
Accepted

Interventions

  • Stable isotope infusion, oral glucose ingestion, intravenous arginine bolus — OTHER
    On separate study days, each participant will have a stable isotope infusion, ingest oral glucose, and be given an intravenous arginine bolus.

Study Details

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.

Key Dates

Start date
Feb 6, 2023
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

The difference in arginine availability [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Children's Hospital / Baylor College of MedicineHoustonTexas77030
Mustafa Tosur, MD
[email protected]

Find similar trials in Houston, TX

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Texas Children's Hospital / Baylor College of Medicine· Houston, TX

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