Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism

NCT ID: NCT02393573

Last Updated: 2018-03-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Metformin

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.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

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

Placebo

Placebo will be administered exactly in the similar way to Metformin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Metformin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mitacs

INDUSTRY

Sponsor Role: collaborator

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Dr. Liane S. Feldman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liane Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

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

Francesco Carli, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

14-264-SDR

Identifier Type: -

Identifier Source: org_study_id