Preoperative Oral Supplementation of Carbohydrate and Branched-Chain Amino Acids-Enriched Nutrient Improves Insulin Resistance in Patients With Hepatectomy; Prospective Randomized Clinical Trial by Using Artificial Pancreas
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- to evaluate the total amount of insulin required for glycemic control after hepatic resection
研究概览
简要总结
To elucidate the effect of preoperative supplementation of carbohydrate and branched-chain amino acids on postoperative insulin resistance in patients undergoing hepatic resection, we set a randomized trial.
详细描述
Twenty-six patients with hepatectomy due to a live tumor were prospectively randomized to receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The present study employed 26 patients, who underwent elective liver resection for hepatocellular carcinoma or adenocarcinoma.
排除标准
- •body weight loss greater than 10 per cent during 6 months prior to the surgery
- •distant metastasis
- •or seriously impaired function of vital organs due to respiratory, renal or heart disease
研究组 & 干预措施
1
receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient
干预措施: Aminolevan EN (Dietary Supplement)
2
receive a preoperative supplementation without carbohydrate and branched-chain amino acids-enriched nutrient
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
to evaluate the total amount of insulin required for glycemic control after hepatic resection
时间窗: total amount of insulin required
次要结局
- to investigate the trends of postoperative blood glucose levels and the incidence of severe hypoglycemia (< 40 mg/dL) by using artificial pancreas during intensive care unit stay(hypoglycemia)