Insulin on Post Burn Hypermetabolism
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Purpose
The purpose of this study is to 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 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 14 |
| Study Start Date: | December 2005 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: Insulin
IV insulin
Drug: Stable Isotopes
IV administration of stable isotopes
Drug: Indocyanine Green
IV administration of ICG
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 72 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Burn equal to or greater than 20% total body surface area (TBSA)
- Between the ages of 18-72 years
- Burns occurred within 14 days of 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
Contacts and Locations| 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 |
More Information
Publications:
| Responsible Party: | United States Army Institute of Surgical Research |
| ClinicalTrials.gov Identifier: | NCT00137254 History of Changes |
| Other Study ID Numbers: | H-05-004, NIH RO-1 GM063120-02 |
| Study First Received: | August 25, 2005 |
| Last Updated: | April 10, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by United States Army Institute of Surgical Research:
|
Severe burns Hyperinsulinemia Insulin |
Muscle protein kinetics Immune function Exercise |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013