Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The effect of intravenously and enterally administered dipeptide alanyl-glutamine preoperatively on postoperative insulin resistance in colon cancer patients.given, on postoperative insulin resistance in colon cancer patients.
研究概览
简要总结
Rationale: It is well known that insulin resistance occurs after mediocre and intensive surgery, such as colon cancer surgery. Disturbances in insulin action negatively affect the postoperative recovery, either by prolonging the capacity of the body to regain normal function, or by increasing the metabolic stress and the risk for complications. Several studies have shown that focusing therapies on improving insulin resistance is successful. Experimental studies have shown that antioxidant agents, like glutamine (a precursor of glutathione), improve insulin sensitivity. The hypothesis of this study is that perioperative parenteral or enteral administration of glutamine, given as the dipeptide alanyl-glutamine, will reduce or prevent postoperative insulin resistance in colon cancer patients. The study will also be focused on the different routes of administration, because of the expected differential metabolic effects.
Objective: The investigators' primary objective is to study whether intravenous or enteral administration of the dipeptide alanyl-glutamine will reduce or prevent postoperative insulin resistance in colon cancer patients.
Study design: A double-blinded, placebo controlled randomised, pilot study at the Surgery Department of the Medical Center Alkmaar.
Study population: Thirty patients of male gender and any ethnicity, who will undergo elective open abdominal colon surgery for colon cancer, aged 18-75 years.
Intervention: Patients will receive dipeptide alanyl-glutamine intravenously or enterally, starting 24 hours prior to surgery, until 24 hours after surgery in the dosage of 0.5 g/kg/day, or saline (control group), for the same period of time.
Main study parameters/endpoints: The main study parameter is postoperative insulin resistance. Secondary study parameters are lipolysis, oxidative stress and glucoregulatory hormones. Muscle, liver and fat biopsies will be taken to study insulin sensitive as well as inflammatory pathways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Colon cancer patients scheduled for elective open abdominal surgery
- •Capable of giving informed consent
排除标准
- •Patients who are participating in another clinical trial
- •Unable to receive oral intake
- •Major malabsorption disorder of the gut
- •Patients with diabetes mellitus
- •BMI above 30 kg/m2
- •Use of certain medication: thyroid medication, corticosteroids, diuretic medication
- •Known bleeding disorders or increased PTT and or APTT
- •Any medical condition except for colon cancer
研究组 & 干预措施
Dipeptiven Arm Enteral
干预措施: Dipeptide Alanyl-Glutamine (Drug)
Placebo Arm Enteral and Intravenously
干预措施: Placebo (Drug)
Dipeptiven ARM Intravenously
干预措施: Dipeptide Alanyl-Glutamine (Drug)
结局指标
主要结局
The effect of intravenously and enterally administered dipeptide alanyl-glutamine preoperatively on postoperative insulin resistance in colon cancer patients.given, on postoperative insulin resistance in colon cancer patients.
时间窗: Before and 1 day after surgery
次要结局
- The effect of the dipeptide alanyl-glutamine on components of the insulin signalling cascade in muscle tissue.(Before and 1 day after surgery)
- The effect of the dipeptide alanyl-glutamine on the systemic inflammatory response as well as on inflammatory pathways in muscle.(Before and 1 day after surgery)
- The effect of the dipeptide alanyl-glutamine on the amino acid concentration in muscle tissue.(Before and 1 day after surgery)
- The effect of the dipeptide alanyl-glutamine on antioxidant/oxidant parameters in the circulating compartment.(Before and 1 day after surgery)
- The effect of dipeptide alanyl-glutamine on the inflammatory response in the liver(During surgery)
- The effect of dipeptide alanyl-glutamine on lipolysis.(Before and 1 day after surgery)
- The effect of dipeptide alanyl-glutamine on key enzymes involved in glucose production.(Before and 1 day after surgery)