Back to resultsAttenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism
Primary Purpose
Pre-Diabetes, Major Lung or Abdominal Surgery, Insulin Resistance
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pre-Diabetes focused on measuring Insulin Resistance, Protein balance, Surgery, Post operative complications, metformin, Pre-diabetes, Fasting blood glucose
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Montreal General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Metformin
Placebo
Arm Description
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.
Placebo will be administered exactly in the similar way to Metformin
Outcomes
Primary Outcome Measures
Change in fasting blood glucose
the level of plasma glucose after 6 hours of fasting
Secondary Outcome Measures
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
Comparing the Homeostasis model assessment (HOMA) index at three different time points ( by employing Fasting blood sugar and Plasma Insulin)
glycosylated Hba1c
plasma level of glycosylated Hba1c
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
Surgical Complications
Any complication related to the surgery with in 30 days post 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
Full Information
NCT ID
NCT02393573
First Posted
February 10, 2015
Last Updated
March 21, 2018
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Mitacs, Medtronic - MITG
1. Study Identification
Unique Protocol Identification Number
NCT02393573
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Mitacs, Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Diabetes, Major Lung or Abdominal Surgery, Insulin Resistance
Keywords
Insulin Resistance, Protein balance, Surgery, Post operative complications, metformin, Pre-diabetes, Fasting blood glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered exactly in the similar way to Metformin
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Patients will take metformin for two weeks before Surgery and 2 days after the surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will take Placebo pills for two weeks before Surgery and 2 days after the surgery
Primary Outcome Measure Information:
Title
Change in fasting blood glucose
Description
the level of plasma glucose after 6 hours of fasting
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 Measure Information:
Title
Change in whole body protein balance
Description
The difference between the Pre-operative whole body protein balance( prior to metformin treatment) and the post operative whole body protein balance
Time Frame
2 weeks before surgery (pre-operative) and hours after the surgery (post operative)
Title
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
Title
glycosylated Hba1c
Description
plasma level of glycosylated Hba1c
Time Frame
2 weeks before surgery
Title
Comparing the pre-operative body impedance and the post operative body impedance (to asses the body composition specifically the amount of body fat)
Description
Measures body composition specifically fat content
Time Frame
2 weeks before surgery and 48 hours after the surgery
Title
Surgical Complications
Description
Any complication related to the surgery with in 30 days post operation
Time Frame
30 days after operation
Title
length of hospital stay
Description
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
Time Frame
Up to 30 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liane Feldman, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Carli, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
12. IPD Sharing Statement
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Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism
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