跳至主要内容
临床试验/NCT00137254
NCT00137254已完成不适用

Effects of Insulin on Post Burn Hypermetabolism

United States Army Institute of Surgical Research1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2005年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
1
主要终点
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

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

A

Active Comparator

干预措施: Insulin (Drug)

A

Active Comparator

干预措施: Stable Isotopes (Drug)

A

Active Comparator

干预措施: Indocyanine Green (Drug)

结局指标

主要结局

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

时间窗: 45 days

To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients

时间窗: 45 days

次要结局

未报告次要终点

研究者

发起方
United States Army Institute of Surgical Research
申办方类型
Fed
责任方
Sponsor

研究点 (1)

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