Examine the effects of insulin on helping burn patients recover faster from their burns,

Condition	Intervention
Burns	Drug: Insulin  Drug: Stable isotopes  Drug: Indocyanine Green

Further Study Details: 

Primary Outcomes: To determine the effect of euglycemic hyperinsulinemia throughout the hospital course on net muscle protein synthesis, and to relate continued muscle anabolism to improved lean body mass and improved functional recovery in severely burned patients.; To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients.
Expected Total Enrollment:  60

Severe injuries produce profound hypermetabolic stress responses which cause severe loss of lean body mass and muscle wasting, immunologic compromise, slowed wound healing, and related bone loss, all which contribute to increased morbidity, mortality, and prolonged recovery from injury. The results of hypermetabolism persist for weeks to months depending on the severity of the insult. Massive burns can cause severe catabolism and are an excellent model to study the general effects of injury on protein metabolism. Severe burns are characterized by dramatic increases in energy utilization and alterations in the metabolism of carbohydrates, fat, and protein.

Insulin treatment improves net protein synthesis in the severely burned, principally through improved muscle protein synthesis. Although controversy exist as to whether insulin is effective as an anabolic hormone through increasing protein synthesis or decreasing protein breakdown, we believe that consideration of the methods and experimental protocols used in the various studies bear consideration when evaluating this topic.

Ages Eligible for Study:  18 Years   -   72 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Burn equal to or greater than 20% TBSA
• Between the ages of 18-72 years
• Burns occurred 72 hours or less before coming to burn center

Exclusion Criteria:

• Heart attack within 3 months
• Have or have had cancer
• Seizure disorder
• Pregnancy
• Pre-existing arterial insufficiency
• Diabetes or known history of hypoglycemia
• Allergy to iodine or shellfish

Please refer to this study by ClinicalTrials.gov identifier  NCT00137254

Nancy C Molter, RN, MSN, PhD      210-916-5690    nancy.molter@amedd.army.mil
Elizabeth Frail, RN, BSN      210-916-8192    elizabeth.frail@amedd.army.mil

Texas
      US Army Institute of Surgical Research, Fort Sam Houston,  Texas,  78234,  United States

Study chairs or principal investigators

Steven E Wolf, MD,  Principal Investigator,  US Army Institute of Surgical Research   

Study ID Numbers:  H-05-004; NIH RO-1 GM063120-02
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00137254
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30