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At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.
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| Name | Class |
|---|---|
| Shriners Hospitals for Children | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin | Active Comparator | Metformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months |
|
| Sugar pill | Placebo Comparator | sugar pill up to 3 times per day for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance | As measured by OGTT | Measure changes between admission and 2 years post burn |
| Measure | Description | Time Frame |
|---|---|---|
| Protein synthesis | As measured by stable isotope infusion study | Measure changes between admission and 1 years post burn |
| Morbidity | As measured by Organ Failure assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David N Herndon, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospitals for Children | Galveston | Texas | 77551 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2023 | |
| Reset | Jul 3, 2023 | |
| Release | Mar 27, 2026 | |
| Reset | Apr 16, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2023 | Jul 3, 2023 | |||
| Mar 27, 2026 |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006943 | Hyperglycemia |
| D002056 | Burns |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D002241 |
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| Sugar pill | Drug | Sugar pill up to 3 times per day for 12 months |
|
|
| Measure changes between admission and 2 years post burn |
| Apr 16, 2026 |
| D014947 | Wounds and Injuries |
| Carbohydrates |