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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01666665
The ClinicalTrials.gov registry entry for NCT01666665 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT01666665 reports 0 study locations.
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.
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