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Sponsors and Collaborators: |
United States Army Institute of Surgical Research The University of Texas, Galveston |
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Information provided by: | United States Army Institute of Surgical Research |
ClinicalTrials.gov Identifier: | NCT00137254 |
The purpose of this study is to examine the effects of insulin on helping burn patients recover faster from their burns.
Condition | Intervention |
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Burns |
Drug: Insulin Drug: Stable Isotopes Drug: Indocyanine Green |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Effects of Insulin on Post Burn Hypermetabolism |
Estimated Enrollment: | 60 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: Insulin
IV insulin
Drug: Stable Isotopes
IV administration of stable isotopes
Drug: Indocyanine Green
IV administration of ICG
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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 to 72 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | USAISR ( Steven E. Wolf, MD ) |
Study ID Numbers: | H-05-004, NIH RO-1 GM063120-02 |
Study First Received: | August 25, 2005 |
Last Updated: | December 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00137254 History of Changes |
Health Authority: | United States: Federal Government |
Severe burns Hyperinsulinemia Insulin |
Muscle protein kinetics Immune function Exercise |
Burns Hyperinsulinism Hypoglycemic Agents |
Wounds and Injuries Disorders of Environmental Origin Insulin |
Burns Hypoglycemic Agents Physiological Effects of Drugs Wounds and Injuries |
Disorders of Environmental Origin Pharmacologic Actions Insulin |