Insulin on Post Burn Hypermetabolism
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ClinicalTrials.gov Identifier: NCT00137254 |
Recruitment Status
:
Completed
First Posted
: August 29, 2005
Last Update Posted
: April 12, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Burns | Drug: Insulin Drug: Stable Isotopes Drug: Indocyanine Green | Not Applicable |
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 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 |

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
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- 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 ]

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Ages Eligible for Study: | 18 Years to 72 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
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

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
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 |
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 Posted: | August 29, 2005 Key Record Dates |
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 |