| Trial ID: | L5911 |
| Source ID: | NCT02393573
|
| Associated Drug: |
Metformin
|
| Title: |
Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism
|
| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Pre-Diabetes|Major Lung or Abdominal Surgery|Insulin Resistance
|
| Interventions: |
DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in fasting blood glucose, the level of plasma glucose after 6 hours of fasting, 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: Change in whole body protein balance, The difference between the Pre-operative whole body protein balance( prior to metformin treatment) and the post operative 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, plasma level of 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), Measures body composition specifically fat content, 2 weeks before surgery and 48 hours after the surgery|Surgical Complications, Any complication related to the surgery with in 30 days post operation, 30 days after operation|length of hospital stay, 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, Up to 30 days after operation
|
| Sponsor/Collaborators: |
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre | Collaborators: Mitacs|Medtronic - MITG
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
7
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-11
|
| Completion Date: |
2018-03
|
| Results First Posted: |
|
| Last Update Posted: |
2018-03-23
|
| Locations: |
Montreal General Hospital, Montreal, Quebec, H3G 1A4, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02393573
|
