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NCT02351323 · ClinicalTrials.gov registry record · Phase 1
Novel Type 2 Diabetes Mellitus Preventive Therapies
A Phase 1 study, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02351323: Completed Phase 1 study, sponsored by Boston Medical Center.
NCT02351323 is a Phase 1 study that has completed, run by Boston Medical Center. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02351323, a Phase 1 study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Over the past two decades, type 2 diabetes mellitus (T2DM) has emerged from relative obscurity to become one of the most serious complications of obesity in Hispanic obese populations, especially among those with a family history of T2DM. Few therapies have demonstrated long term efficacy in combating obesity and risk of T2DM in youth. Given the emerging evidence that glutamine and leucine (building blocks of protein) may affect energy partition and thus diabetes risk, and that the relationship of glutamine and diabetic risk has been further evaluated in one adult observational cohort study but data on leucine are lacking, we plan to conduct a clinical trial to determine the efficacy of glutamine to reduce insulin resistance, a diabetes risk factor. The primary specific aim of the research plan is to conduct a randomized, double-blind, placebo controlled, clinical trial to test the efficacy of 6 months supplements of glutamine in reducing biomarkers for insulin resistance and weight gain among 56 obese Hispanic adolescents age 12-19 years with a BMI at or above the 95th percentile and a family history of T2DM. At the end of the grant period, we will have obtained preliminary data to plan pivotal clinical trials of glutamine coupled with or without lifestyle changes.
Interventions
- DRUG Glutamine (Pharmacological doses)
- BEHAVIORAL Lifestyle change
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT02351323 record still lists
NCT02351323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Glutamine (Pharmacological doses) is the first listed.
NCT02351323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02351323 about?
NCT02351323 is a clinical study titled "Novel Type 2 Diabetes Mellitus Preventive Therapies". Over the past two decades, type 2 diabetes mellitus (T2DM) has emerged from relative obscurity to become one of the most serious complications of obesity in Hispanic obese populations, especially among those with a family history of T2DM. Few therapies have demonstrated long term efficacy in combati...
What is the current status of trial NCT02351323?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT02351323?
The interventions under investigation include: Glutamine (Pharmacological doses) (DRUG), Lifestyle change (BEHAVIORAL).
Who is sponsoring clinical trial NCT02351323?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02351323's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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