drugset / Trial / NCT01666665

Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin

NCT01666665

RandomizedSingle-groupSingle-blindTreatment

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.

Timeline

Start
2012-11
Primary completion
2018-08
Completion
2019-04-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 1000 mg/m2 Oral

Indications