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

• Status: Terminated
• Trial end date: 2019-04-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Collaborator: Shriners Hospitals for Children
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Patient age 10-19

• Primary diagnosis of ≥ 20 Total Burn Surface Area Burn (TBSAB )

Exclusion Criteria:

• Decision not to treat due to burn injury severity

• Known history of AIDS, ARC, HIV

• Pregnancy

• Previous diagnosis (pre -burn) of renal failure, liver disease or hepatic dysfunction- Serum Creatinine >1.5mg/dL for males and >1.4mg/dL for females, after fluid resuscitation (Clinical definition of kidney damage)

• Pre-existing type 1 diabetes mellitus

• Pre Existing type 2 diabetes mellitus and receiving treatment

• Allergies to Metformin

• Acute or chronic acidosis (lactic or any other metabolic type) and renal failure