Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism In Patients Undergoing Major Lung or Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in fasting blood glucose
研究概览
简要总结
Major surgery results in a stress- induced catabolic response, marked by post-operative insulin resistance, hyperglycemia and loss of body protein, which is associated with increased morbidity, mortality and adverse outcomes. There has been a great deal of research on different approaches to optimize post-operative insulin sensitivity including hormonal and nutritional interventions, minimally invasive surgical techniques and epidural anesthesia. However, the correlation between insulin resistance and body protein loss is not well understood. Metformin is the most widely used insulin sensitizing and blood glucose-lowering drug in treatment of type 2 diabetic patients. This study will: 1) estimate the correlation between insulin resistance and body protein loss in pre-diabetic lung/colorectal resection patients; 2) investigate whether the post-operative metabolic state can be improved by the pre-operative administration of metformin; and assess the impact of metformin on surgical complications and hospital length of stay. The results of this study will provide insight into the relationship between insulin resistance and post-operative adverse events and potentially suggest a novel approach to improve outcomes using Metformin, a drug already in wide clinical use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective open anatomic lung resections: segmentectomy, lobectomy, bi-lobectomy
- •Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
- •Primary or secondary lung cancer
- •At least 18 years of age with
- •HbA1c 5.7- 6.5 %
- •Not receiving any kind of glucose lowering medication.
排除标准
- •Already diagnosed with diabetes (Hb A1c > 6.5%)
- •Are pre-diabetic receiving glucose lowering intervention ( any glucose lowering medication)
- •Have renal or liver dysfunction (serum creatinine above 124 micromol/L in women and 133 micromol/L in men, bilirubin >50 micromol/L)
- •will undergo extended resection of adjacent organs, chest wall resections, bronchoplasty, non-anatomic lung resections
- •Will undergo Pneumonectomy
- •Non-elective operations
- •Have mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis),
- •Have cardiac abnormalities, severe end-organ disease such as cardiac failure (New York Heart Association classes III-IV), Chronic obstructive pulmonary disease(COPD), sepsis, morbid obesity (BMI >40 kg/m2), anemia (hematocrit < 30 %, hemoglobin <100g/L albumin < 25mg/dl)
- •Have received steroids for longer than 30 days
- •Have poor English or French comprehension.
研究组 & 干预措施
Metformin
Metformin will be administered as pills to be taken orally with an initial dose of 850 mg on the first day; the dose will be increased to 850 mg every 12 hours and 850mg every 8 hours respectively on the second day and then on the days to follow up to the morning of the surgery. Metformin will be discontinued on the day of surgery and will be restarted immediately after surgery.
干预措施: Metformin (Drug)
Placebo
Placebo will be administered exactly in the similar way to Metformin
干预措施: Placebo (Drug)
结局指标
主要结局
Change in fasting blood glucose
时间窗: 2 weeks before surgery (pre-operative) and on the morning before the surgery and every morning after the surgery (post operative) for three days or until discharge which ever comes earlier
the level of plasma glucose after 6 hours of fasting
次要结局
- Change in whole body protein balance(2 weeks before surgery (pre-operative) and hours after the surgery (post operative))
- Comparing the Homeostasis model assessment (HOMA) index at three different time points ( by employing Fasting blood sugar and Plasma Insulin)(at 3 time points as follow : 2 weeks before surgery, on the day of surgery and 48 hours after the surgery)
- glycosylated Hba1c(2 weeks before surgery)
- Comparing the pre-operative body impedance and the post operative body impedance (to asses the body composition specifically the amount of body fat)(2 weeks before surgery and 48 hours after the surgery)
- Surgical Complications(30 days after operation)
- length of hospital stay(Up to 30 days after operation)
研究者
Dr. Liane S. Feldman
Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre