Pre-operative Carbohydrate Drink to Preserve Peri-operative Insulin Sensitivity

NCT ID: NCT02673502

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-05-31

Brief Summary

Enhanced Recovery after Surgery (ERAS) pathways include multiple evidence-based interventions delivered throughout the peri-operative period that aim to attenuate the surgical stress response and support rapid physiologic and functional recovery.A key element of the ERAS pathway is the administration of a clear carbohydrate-rich beverage 2-3 h before surgery in order to keep the patient in a fed state rather than a fasted state when they go to the operating room. The aim of the current study is to investigate the impact of a drink containing simple carbohydrate on attenuating surgical stress induced insulin resistance in patients undergoing major laparoscopic abdominal surgery, compared to drinks containing maltodextrin.

Conditions

Laparoscopic Abdominal Surgery

Study Design

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

Study Groups

simple carbohydrate drink

Patients will ingest 400 ml of the simple carbohydrate drink consisting of commercial orange juice without pulp which contains 50 grams fructose/galactose 2 hours before surgery.

Group Type: EXPERIMENTAL

simple carbohydrate drink

Intervention Type: DIETARY_SUPPLEMENT

Patients will ingest 400 ml of the simple carbohydrate drink consisting of commercial orange juice without pulp which contains 50 grams fructose/galactose 2 hours before surgery.

complex carbohydrate drink

Patients will ingest 400 ml of the complex carbohydrate drink containing 50 grams of maltodextrin powder in water ( orange food color and artificial orange flavor have been added to the drink) 2 hours before surgery.

Group Type: EXPERIMENTAL

complex carbohydrate drink

Intervention Type: DIETARY_SUPPLEMENT

Patients will ingest 400 ml of the complex carbohydrate drink containing 50 grams of maltodextrin powder in water ( orange food color and artificial orange flavor have been added to the drink) 2 hours before surgery

Interventions

simple carbohydrate drink

Patients will ingest 400 ml of the simple carbohydrate drink consisting of commercial orange juice without pulp which contains 50 grams fructose/galactose 2 hours before surgery.

Intervention Type: DIETARY_SUPPLEMENT

complex carbohydrate drink

Patients will ingest 400 ml of the complex carbohydrate drink containing 50 grams of maltodextrin powder in water ( orange food color and artificial orange flavor have been added to the drink) 2 hours before surgery

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. At least 18 years of age

2. Planned laparoscopic partial colon resection for non-metastatic neoplastic or benign disease (including right, transverse, left or sigmoid))

3. HbA1c less than or equal to 5.7%

4. Not receiving any kind of glucose lowering medication.

Exclusion Criteria

1. Are already diagnosed with diabetes or pre diabetes (HbA1c > 5.7%)

2. Are pre-diabetic receiving glucose lowering intervention (any glucose lowering medication)

3. Have renal or liver dysfunction (serum creatinine above 1.4 mg/dL in women and 1.5 mg/dL in men, bilirubin >2.9 mg/dL)

4. Will undergo extended resection of adjacent organs

5. Non-elective operations

6. New stoma created

7. Have conditions precluding participation in the ERAS pathway (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)

8. Have conditions requiring preoperative fasting: documented gastroparesis, patient on metoclopramide and/or domperidone, achalasia, dysphagia (any difficulty with swallowing), or Fluid restriction (e.g. dialysis, pulmonary oedema, congestive heart failure).

9. Have cardiac abnormalities, severe end-organ disease such as cardiac failure (New York Heart Association classes III-IV), chronic obstructive pulmonary disease (documented by abnormal pulmonary function test), morbid obesity (BMI >40 kg/m2), anemia (hematocrit < 30 %, hemoglobin <100g/L, albumin < 25mg/dl)

10. Have received steroids for longer than 30 days

11. 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

15-162-MUHC

Identifier Type: -

Identifier Source: org_study_id