Clinical trial NCT02393573: Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism
Official title: Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism In Patients Undergoing Major Lung or Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pre-Diabetes
Major Lung or Abdominal Surgery
Insulin Resistance
Keywords: Insulin Resistance
Protein balance
Surgery
Post operative complications
metformin
Pre-diabetes
Fasting blood glucose
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Mitacs
name: Medtronic - MITG
First posted: 2015-03-19
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in fasting blood glucose
timeFrame: 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
Secondary outcomes:
measure: Change in whole body protein balance
timeFrame: 2 weeks before surgery (pre-operative) and hours after the surgery (post operative)
measure: Comparing the Homeostasis model assessment (HOMA) index at three different time points ( by employing Fasting blood sugar and Plasma Insulin)
timeFrame: at 3 time points as follow : 2 weeks before surgery, on the day of surgery and 48 hours after the surgery
measure: glycosylated Hba1c
timeFrame: 2 weeks before surgery
measure: Comparing the pre-operative body impedance and the post operative body impedance (to asses the body composition specifically the amount of body fat)
timeFrame: 2 weeks before surgery and 48 hours after the surgery
measure: Surgical Complications
timeFrame: 30 days after operation
measure: length of hospital stay
timeFrame: Up to 30 days after operation
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Liane Feldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Francesco Carli, MD
role: PRINCIPAL_INVESTIGATOR
References: