Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 19 |
| Updated: | 9/12/2018 |
| Start Date: | November 2012 |
| End Date: | August 2020 |
| Contact: | Catherine Reed, RN, BSN |
| Email: | ca2reed@utmb.edu |
| Phone: | 409-770-6987 |
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.
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.
Metformin treated patients will be compared to control patients. Both groups will receive
insulin therapy for blood glucose >180mg/dl. Insulin will be titrated according to hospital
sliding scale.
The use of insulin or metformin will benefit burned children by improving muscle protein
build-up, speeding wound healing and reversing growth arrest, improving the immune response,
and positively affecting long-term rehabilitation.
The results of this study may initiate a change in standard of care as it is found that
simply the reduction of blood glucose by metformin, improves patient outcomes as metformin
can be administered without the added complication of hypoglycemia.
insulin therapy for blood glucose >180mg/dl. Insulin will be titrated according to hospital
sliding scale.
The use of insulin or metformin will benefit burned children by improving muscle protein
build-up, speeding wound healing and reversing growth arrest, improving the immune response,
and positively affecting long-term rehabilitation.
The results of this study may initiate a change in standard of care as it is found that
simply the reduction of blood glucose by metformin, improves patient outcomes as metformin
can be administered without the added complication of hypoglycemia.
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
We found this trial at
1
site
Galveston, Texas 77555
Principal Investigator: David N Herndon, MD
Phone: 409-770-6987
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