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NCT01666665 · ClinicalTrials.gov registry record · Phase 2
Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin
A Phase 2 study, sponsored by The University of Texas Medical Branch, Galveston.
- Terminated
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01666665: Clinical Trial Phase 2 study, sponsored by The University of Texas Medical Branch, Galveston.
NCT01666665 is a Phase 2 study that was terminated before completion, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01666665, a Phase 2 study, was terminated before completion, sponsored by The University of Texas Medical Branch, Galveston.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
Massive pediatric burns are associated with a persistent and sustained hypermetabolic response characterized by elevated levels of circulating catecholamine's, cortisol, and glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound healing. Insulin and metformin have demonstrated anabolic activity with minimal associated side effects. However, it is unknown whether the beneficial effects arise from tight euglycemic control or direct effect of insulin action. We hypothesize that during acute hospitalization, administration of metformin at a dose titrated to maintain blood glucose between 80-180 mg/dl will accelerate wound healing and recovery in children with severe thermal injury and will have beneficial long-term effects on muscle strength, immune function, and wound healing.
Primary Outcome
As measured by OGTT
Interventions
- DRUG Metformin
- DRUG Sugar pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-11 |
| Est. Completion | 2019-04-23 |
| Phase | Phase 2 |
Why NCT01666665 stopped before completion
NCT01666665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT01666665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01666665 about?
NCT01666665 is a clinical study titled "Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin". Massive pediatric burns are associated with a persistent and sustained hypermetabolic response characterized by elevated levels of circulating catecholamine's, cortisol, and glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound healing. Insulin and metformin have d...
What is the current status of trial NCT01666665?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2012-11. Estimated completion is 2019-04-23.
What interventions are being tested in trial NCT01666665?
The interventions under investigation include: Metformin (DRUG), Sugar pill (DRUG).
Who is sponsoring clinical trial NCT01666665?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01666665's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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