Insulin Resistance, Major Lung or Abdominal Surgery, Pre-Diabetes
Conditions
Keywords
Insulin Resistance, Protein balance, Surgery, Post operative complications, metformin, Pre-diabetes, Fasting blood glucose
Brief summary
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.
Interventions
DRUGMetformin
Patients will take metformin for two weeks before Surgery and 2 days after the surgery
DRUGPlacebo
Patients will take Placebo pills for two weeks before Surgery and 2 days after the surgery
Sponsors
Mitacs
Medtronic - MITG
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Elective open anatomic lung resections: segmentectomy, lobectomy, bi-lobectomy 2. Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy) 3. Primary or secondary lung cancer 4. At least 18 years of age with 5. HbA1c 5.7- 6.5 % 6. Not receiving any kind of glucose lowering medication.
Exclusion criteria
1. Already diagnosed with diabetes (Hb A1c \> 6.5%) 2. Are pre-diabetic receiving glucose lowering intervention ( any glucose lowering medication) 3. Have renal or liver dysfunction (serum creatinine above 124 micromol/L in women and 133 micromol/L in men, bilirubin \>50 micromol/L) 4. will undergo extended resection of adjacent organs, chest wall resections, bronchoplasty, non-anatomic lung resections 5. Will undergo Pneumonectomy 6. Non-elective operations 7. Have mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), 8. 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) 9. Have received steroids for longer than 30 days 10. Have poor English or French comprehension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting blood glucose | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | plasma level of glycosylated Hba1c |
| Change in whole body protein balance | 2 weeks before surgery (pre-operative) and hours after the surgery (post operative) | The difference between the Pre-operative whole body protein balance( prior to metformin treatment) and the post operative whole body protein balance |
| Surgical Complications | 30 days after operation | Any complication related to the surgery with in 30 days post operation |
| length of hospital stay | Up to 30 days after operation | Length of hospital stay is calculated as the total length of hospitalization from the date of admission for the purpose of surgery until the date of discharge from the hospital |
| 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 | Measures body composition specifically fat content |
Countries
Canada
Outcome results
None listed