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Insulin on Post Burn Hypermetabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00137254
First Posted: August 29, 2005
Last Update Posted: April 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The University of Texas Medical Branch, Galveston
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Insulin on Post Burn Hypermetabolism

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • 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 ]
  • To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients [ Time Frame: 45 days ]

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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137254


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

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
First Submitted: August 25, 2005
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