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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01666665
• Other study ID #: 12-142
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: November 2012
• Est. completion date: April 23, 2019

Study information

• Verified date: August 2018
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: April 23, 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Hypermetabolism
• Insulin Resistance

Intervention

Drug:
• Metformin
Metformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months
• Sugar pill
Sugar pill up to 3 times per day for 12 months

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance	As measured by OGTT	Measure changes between admission and 2 years post burn
Secondary	Protein synthesis	As measured by stable isotope infusion study	Measure changes between admission and 1 years post burn
Secondary	Morbidity	As measured by Organ Failure assessments	Measure changes between admission and 2 years post burn