Insulin on Post Burn Hypermetabolism

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Burns	Drug: Insulin; Drug: Stable Isotopes; Drug: Indocyanine Green	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effects of Insulin on Post Burn Hypermetabolism
Study Start Date :	December 2005
Actual Primary Completion Date :	February 2007
Actual Study Completion Date :	August 2008

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: A	Drug: Insulin; IV insulin Drug: Stable Isotopes; IV administration of stable isotopes Drug: Indocyanine Green; IV administration of ICG

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
2. To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients [ Time Frame: 45 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 72 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

United States Army Institute of Surgical Research

The University of Texas Medical Branch, Galveston

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Ferrando AA, Chinkes DL, Wolf SE, Matin S, Herndon DN, Wolfe RR. A submaximal dose of insulin promotes net skeletal muscle protein synthesis in patients with severe burns. Ann Surg. 1999 Jan;229(1):11-8.

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
First Posted:	August 29, 2005
Last Update Posted:	April 12, 2012
Last Verified:	April 2012

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, Globin Zinc	Insulin; Hypoglycemic Agents; Physiological Effects of Drugs