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Insulin on Post Burn Hypermetabolism
This study is ongoing, but not recruiting participants.
First Received: August 25, 2005   Last Updated: December 25, 2007   History of Changes
Sponsors and Collaborators: United States Army Institute of Surgical Research
The University of Texas, Galveston
Information provided by: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00137254
  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

MedlinePlus related topics: Burns
Drug Information available for: Insulin Indocyanine green
U.S. FDA Resources
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

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 ] [ 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 ]

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
A: Active Comparator 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
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, Galveston
Investigators
Principal Investigator: Steven E Wolf, MD US Army Institute of Surgical Research
  More Information

Publications:
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

Keywords provided by United States Army Institute of Surgical Research:
Severe burns
Hyperinsulinemia
Insulin
Muscle protein kinetics
Immune function
Exercise

Study placed in the following topic categories:
Burns
Hyperinsulinism
Hypoglycemic Agents
Wounds and Injuries
Disorders of Environmental Origin
Insulin

Additional relevant MeSH terms:
Burns
Hypoglycemic Agents
Physiological Effects of Drugs
Wounds and Injuries
Disorders of Environmental Origin
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009