Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism

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.

Conditions

• Pre-Diabetes
• Major Lung or Abdominal Surgery
• Insulin Resistance

Interventions

DRUG

Metformin

Patients will take metformin for two weeks before Surgery and 2 days after the surgery

DRUG

Placebo

Patients will take Placebo pills for two weeks before Surgery and 2 days after the surgery

Sponsors & Collaborators

• Mitacs

  collaborator INDUSTRY

• Medtronic - MITG

  collaborator INDUSTRY

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Liane Feldman, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Francesco Carli, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2018-03-31

Completion

2018-03-31

Countries

• Canada

Study Locations