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Insulin on Post Burn Hypermetabolism

U

United States Army Institute of Surgical Research

Status

Completed

Conditions

Burns

Treatments

Drug: Insulin
Drug: Indocyanine Green
Drug: Stable Isotopes

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00137254
NIH RO-1 GM063120-02
H-05-004

Details and patient eligibility

About

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

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 72 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

A
Active Comparator group
Treatment:
Drug: Stable Isotopes
Drug: Indocyanine Green
Drug: Insulin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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