Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Insulin resistance
研究概览
简要总结
Massive pediatric burns are associated with a persistent and sustained hypermetabolic response characterized by elevated levels of circulating catecholamine's, cortisol, and glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound healing. Insulin and metformin have demonstrated anabolic activity with minimal associated side effects. However, it is unknown whether the beneficial effects arise from tight euglycemic control or direct effect of insulin action. We hypothesize that during acute hospitalization, administration of metformin at a dose titrated to maintain blood glucose between 80-180 mg/dl will accelerate wound healing and recovery in children with severe thermal injury and will have beneficial long-term effects on muscle strength, immune function, and wound healing.
详细描述
Metformin treated patients will be compared to control patients. Both groups will receive insulin therapy for blood glucose >180mg/dl. Insulin will be titrated according to hospital sliding scale.
The use of insulin or metformin will benefit burned children by improving muscle protein build-up, speeding wound healing and reversing growth arrest, improving the immune response, and positively affecting long-term rehabilitation.
The results of this study may initiate a change in standard of care as it is found that simply the reduction of blood glucose by metformin, improves patient outcomes as metformin can be administered without the added complication of hypoglycemia.
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
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 10-19
- •Primary diagnosis of ≥ 20 Total Burn Surface Area Burn (TBSAB )
排除标准
- •Decision not to treat due to burn injury severity
- •Known history of AIDS, ARC, HIV
- •Pregnancy
- •Previous diagnosis (pre -burn) of renal failure, liver disease or hepatic dysfunction- Serum Creatinine >1.5mg/dL for males and >1.4mg/dL for females, after fluid resuscitation (Clinical definition of kidney damage)
- •Pre-existing type 1 diabetes mellitus
- •Pre Existing type 2 diabetes mellitus and receiving treatment
- •Allergies to Metformin
- •Acute or chronic acidosis (lactic or any other metabolic type) and renal failure
研究组 & 干预措施
metformin
Metformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months
干预措施: Metformin (Drug)
Sugar pill
sugar pill up to 3 times per day for 12 months
干预措施: Sugar pill (Drug)
结局指标
主要结局
Insulin resistance
时间窗: Measure changes between admission and 2 years post burn
As measured by OGTT
次要结局
- Protein synthesis(Measure changes between admission and 1 years post burn)
- Morbidity(Measure changes between admission and 2 years post burn)