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Amino Acid

Arginine Metabolism Study for Youth with Type 2 Diabetes

N/A

Recruiting

Led By Mustafa Tosur, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age criteria: 12- to 20-year-old girls who are postmenarchal, and 14- to 20-year-old boys who are at Tanner stage 5 genitalia

Be younger than 65 years old

Must not have

Renal insufficiency defined by eGFR (estimated glomerular filtration rate) <90 mL/min/1.73 m2

Current use of exogenous insulin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

No Placebo-Only Group

Summary

This trial explores how diabetes affects kids by looking at how their bodies process nutrients, specifically arginine. They will also test if giving kids extra arginine can help improve their diabetes outcomes.

Who is the study for?

This trial is for young people with Type 2 Diabetes, aged 12-20 years. Girls must be postmenarchal and boys at Tanner stage 5 genitalia. Participants should have been diagnosed with T2D for 3 months to 10 years. Those on hormonal therapy, insulin, or certain medications, or with other health issues like abnormal liver function or pregnancy cannot join.

What is being tested?

The study investigates how the body processes arginine in youths with Type 2 Diabetes by using stable isotope tracers and oral glucose tests. It also examines if taking extra arginine can help improve the function of cells that make insulin.

What are the potential side effects?

Since this trial involves nutritional supplements and diagnostic tests rather than drugs, side effects are expected to be minimal but may include discomfort from blood draws or mild reactions to the glucose and arginine given during testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a girl aged 12-20 years postmenarchal or a boy aged 14-20 years at Tanner stage 5.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced with an eGFR below 90 mL/min/1.73 m2.

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I am currently using insulin injections.

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I am taking diabetes medication other than metformin.

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I am on hormone replacement therapy.

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I have had diabetic ketoacidosis in the past.

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I have abnormal liver, thyroid, gonadal, or adrenal functions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The difference in arginine availability

Secondary study objectives

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 sensitivity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: The study cohort consisting of youth with type 2 diabetes and healthy controlsExperimental Treatment1 Intervention

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.

0 / 7Eligibility criteria met