Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism

Insulin Resistance Clinical Trial

Official title:

Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism In Patients Undergoing Major Lung or Abdominal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02393573
• Other study ID #: 14-264-SDR
• Status: Terminated
• Phase: N/A
• First received: February 10, 2015
• Last updated: March 21, 2018
• Start date: November 2015
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Insulin Resistance
• Major Lung or Abdominal Surgery
• Pre-Diabetes
• Prediabetic State

Intervention

Drug:
• Metformin
Patients will take metformin for two weeks before Surgery and 2 days after the surgery
• Placebo
Patients will take Placebo pills for two weeks before Surgery and 2 days after the surgery

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Center	Medtronic - MITG, Mitacs

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)
Secondary	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
Secondary	glycosylated Hba1c	plasma level of glycosylated Hba1c	2 weeks before surgery
Secondary	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
Secondary	Surgical Complications	Any complication related to the surgery with in 30 days post operation	30 days after operation
Secondary	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