Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02393573
• Date of registration: 10/02/2015
• Prospective Registration: Yes
• Primary sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Public title: Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism
• Scientific title: Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism In Patients Undergoing Major Lung or Abdominal Surgery
• Date of first enrolment: November 2015
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02393573
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Francesco Carli, MD
• Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre

• Name: Liane Feldman, MD
• Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Major Lung or Abdominal Surgery

Pre-Diabetes

Insulin Resistance

Intervention(s)

Drug: Metformin

Drug: Placebo

Primary Outcome(s)

Change in fasting blood glucose [Time Frame: 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 Outcome(s)

length of hospital stay [Time Frame: Up to 30 days after operation]

Comparing the Homeostasis model assessment (HOMA) index at three different time points ( by employing Fasting blood sugar and Plasma Insulin) [Time Frame: at 3 time points as follow : 2 weeks before surgery, on the day of surgery and 48 hours after the surgery]

Comparing the pre-operative body impedance and the post operative body impedance (to asses the body composition specifically the amount of body fat) [Time Frame: 2 weeks before surgery and 48 hours after the surgery]

Change in whole body protein balance [Time Frame: 2 weeks before surgery (pre-operative) and hours after the surgery (post operative)]

Surgical Complications [Time Frame: 30 days after operation]

glycosylated Hba1c [Time Frame: 2 weeks before surgery]

Secondary ID(s)

14-264-SDR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medtronic - MITG

Mitacs