Stable isotope infusion, oral glucose ingestion, intravenous arginine bolus for Type 2 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Texas Children's Hospital / Baylor College of Medicine, Houston, TX
Type 2 Diabetes Mellitus+2 More
Stable isotope infusion, oral glucose ingestion, intravenous arginine bolus - Other
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

Type 2 diabetes (T2D), once considered only "a disease of older ages," is now a significant public health concern in children. 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 pediatric 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 children with T2D, potentially supporting the use of this safe, low-cost, and readily available nutrient to improve pediatric diabetes outcomes.

Eligible Conditions

  • Type 2 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 1 day

1 day
The difference in arginine availability
The difference in insulin secretion and the effect of intravenous arginine bolus on insulin secretion
The difference in insulin sensitivity and the effect of intravenous arginine bolus on insulin sensiitivity
The difference in insulin sensitivity and the effect of intravenous arginine bolus on insulin sensitivity

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

The study cohort consisting of children with type 2 diabetes and healthy control...
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Stable isotope infusion, oral glucose ingestion, intravenous arginine bolus · No Placebo Group · N/A

The study cohort consisting of children with type 2 diabetes and healthy controls
Other
Experimental Group · 1 Intervention: Stable isotope infusion, oral glucose ingestion, intravenous arginine bolus · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 day
Closest Location: Texas Children's Hospital / Baylor College of Medicine · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
2010First Recorded Clinical Trial
1 TrialsResearching Type 2 Diabetes Mellitus
4 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,094 Previous Clinical Trials
5,051,463 Total Patients Enrolled
117 Trials studying Type 2 Diabetes Mellitus
77,874 Patients Enrolled for Type 2 Diabetes Mellitus
Baylor College of MedicineLead Sponsor
910 Previous Clinical Trials
5,981,736 Total Patients Enrolled
10 Trials studying Type 2 Diabetes Mellitus
649 Patients Enrolled for Type 2 Diabetes Mellitus
Mustafa Tosur, MDPrincipal InvestigatorBaylor College of Medicine

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Children with type 2 diabetes and healthy controls who meet other inclusion criteria outlined below.
You are aged 12 to 17 years and are either postmenarchal or at Tanner stage 5 pubic hair.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.