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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 is a Phase 1 study that has completed, run by Boston Medical Center. The registered enrollment target is 12 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02351323
The ClinicalTrials.gov registry entry for NCT02351323 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Glutamine (Pharmacological doses) is the first listed.
NCT02351323 reports 0 study locations.
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.
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