Arginine Metabolism in Youth With Type 2 Diabetes

NCT05477134 | Recruiting

• 1 other identifier: H-51936
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Children; Pediatric type 2 diabetes; Pediatric diabetes; Arginine; Youth

Outcome Measures

Primary Outcomes (1)

• The difference in arginine availability

  Arginine availability will be assessed and compared between youth with type 2 diabetes and healthy controls.

  1 day

Secondary Outcomes (2)

• The difference in insulin secretion and the effect of intravenous arginine bolus on insulin secretion

  1 day

• The difference in insulin sensitivity and the effect of intravenous arginine bolus on insulin sensitivity

  1 day

Study Arms (1)

The study cohort consisting of youth with type 2 diabetes and healthy controls

EXPERIMENTAL

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.

Other: Stable isotope infusion, oral glucose ingestion, intravenous arginine bolus

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.

The study cohort consisting of youth with type 2 diabetes and healthy controls

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Previous history of diabetic ketoacidosis (DKA)
• Poorly controlled diabetes defined as HbA1c \>7.5%,
• Abnormal liver, thyroid, gonadal or adrenal functions,
• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Texas Children's Hospital / Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mustafa Tosur, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Tosur, MD

CONTACT

832-822-3780; mustafa.tosur@bcm.edu

Lori Malone

CONTACT

832-822-3784; lmalone@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 28, 2022
• Study Start: February 6, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)