Insulin on Post Burn Hypermetabolism
The purpose of this study is to examine the effects of insulin on helping burn patients recover faster from their burns.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Insulin on Post Burn Hypermetabolism|
- 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 [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
- To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients [ Time Frame: 45 days ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Study Completion Date:||August 2008|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
IV insulinDrug: Stable Isotopes
IV administration of stable isotopesDrug: Indocyanine Green
IV administration of ICG
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137254
|United States, Texas|
|US Army Institute of Surgical Research|
|Fort Sam Houston, Texas, United States, 78234|
|Principal Investigator:||Steven E Wolf, MD||US Army Institute of Surgical Research|