Insulin on Post Burn Hypermetabolism

Study Overview
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Brief Summary
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The purpose of this study is to examine the effects of insulin on helping burn patients recover faster from their burns.

Detailed Description
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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.

Official Title
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Effects of Insulin on Post Burn Hypermetabolism

Conditions
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Burns

Intervention / Treatment
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* Drug: Insulin
* Drug: Stable Isotopes
* Drug: Indocyanine Green


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Insulin<br>* IV insulin<br>Drug: Stable Isotopes<br>* IV administration of stable isotopes<br>Drug: Indocyanine Green<br>* IV administration of ICG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 45 days | 
| To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients |  | 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe burns, Hyperinsulinemia, Insulin, Muscle protein kinetics, Immune function, Exercise