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NCT01467063 · ClinicalTrials.gov registry record · NA
Glutamine and Insulin Sensitivity in Type I Diabetes
A NA study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT01467063: Completed NA study, sponsored by Nemours Children's Clinic.
NCT01467063 is a NA study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01467063, a NA study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
Insulin is crucial to help the body metabolize ('burn') sugar (glucose). Even though juvenile (type 1) diabetes (T1D) is primarily due to the lack of insulin, patients with T1D tend to become less sensitive to insulin, particularly during adolescence. The overall objective of this project is to gain further insight into the possible benefits of supplementation with glutamine (GLN), a natural dietary amino acid, enhancing insulin sensitivity in adolescents with T1D. To elucidate the impact of glutamine, the investigators will use a method called the 'euglycemic, hyperinsulinemic clamp': it consists of giving an IV drip of insulin, while the drop in blood sugar is prevented by giving variable, precisely measured amounts of glucose by vein: the amount of glucose required to prevent a drop in blood sugar reflects the body's sensitivity to insulin. The investigators will also give an IV drip of glucose and arginine (a building block of protein) 'tagged' with non-radioactive isotopes to better understand how glutamine may work. This procedure will be performed in 2 groups of 10 adolescents in the morning either after a strenuous exercise performed the previous afternoon (group 1; n=10), or after a sedentary day (group 2; n=10). Each subject will be studied twice, once after taking oral GLN, once after placebo, in separate clinical research center (CRC) admissions a few weeks apart, in random order. Should the investigators hypothesis prove to be true, it would warrant long term studies to determine whether sustained dietary GLN supplementation can decrease insulin requirements and ultimately improve diabetes control in teenagers with T1DM, If successful, this approach could potentially have a significant positive impact in terms of adolescent health.
Primary Outcome
Insulin sensitivity as measured by hyperinsulinemic-euglycemic clamp. Insulin sensitivity was calculated by dividing the average glucose infusion rate (mL glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL).
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Glutamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-07 |
| Phase | NA |
What the finished NCT01467063 record still lists
NCT01467063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01467063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01467063 about?
NCT01467063 is a clinical study titled "Glutamine and Insulin Sensitivity in Type I Diabetes". Insulin is crucial to help the body metabolize ('burn') sugar (glucose). Even though juvenile (type 1) diabetes (T1D) is primarily due to the lack of insulin, patients with T1D tend to become less sensitive to insulin, particularly during adolescence. The overall objective of this project is to gai...
What is the current status of trial NCT01467063?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2011-10. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01467063?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Glutamine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01467063?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01467063's enrollment target sits among peer trials
13 1911th of 2000 higher than 88 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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