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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a girl aged 12-20 years postmenarchal or a boy aged 14-20 years at Tanner stage 5.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The difference in arginine availability
Secondary outcome measures
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
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, Na13CO3, and 13C5-Orn.
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.
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,222 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,465 Total Patients Enrolled
Mustafa Tosur, MDPrincipal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your diabetes is not well controlled, with HbA1c higher than 8%.I am not on medications that affect amino acid metabolism.I am a young person with type 2 diabetes.I am a girl aged 12-20 years postmenarchal or a boy aged 14-20 years at Tanner stage 5.My kidney function is reduced with an eGFR below 90 mL/min/1.73 m2.I am a young person with Type 2 Diabetes for 3 months to 10 years.I am currently using insulin injections.I am taking diabetes medication other than metformin.I am on hormone replacement therapy.I have had diabetic ketoacidosis in the past.I have abnormal liver, thyroid, gonadal, or adrenal functions.
Research Study Groups:
This trial has the following groups:- Group 1: The study cohort consisting of youth with type 2 diabetes and healthy controls
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots for new participants in this experiment?
"This study, as indicated on clinicaltrials.gov, is not recruiting patients at the moment. However, this may change in the future as the trial was first posted on September 1st, 2022 and was most recently updated on August 4th, 2022. Additionally, there are 1509 other studies that are actively enrolling patients currently."
Answered by AI
Does this research study allow people who are over 30 years old to participate?
"This trial is for children aged 12-17. Out of 1,363 total clinical trials, this study is one of 199 that specifically includes patients under 18 years old."
Answered by AI
Might I be eligible to participate in this research?
"Up to 30 adolescents with type 2 diabetes mellitus may participate in this trial, so long as they meet the age (12-17) and pubertal stage criteria. For patients with T2D, their disease must also have been diagnosed within the last 10 years. Lastly, healthy controls must meet all other inclusion criteria not mentioned here."
Answered by AI
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