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

McGill University

Status: Completed

Conditions: Laparoscopic Abdominal Surgery

Treatments: Dietary Supplement: complex carbohydrate drink; Dietary Supplement: simple carbohydrate drink

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02673502

15-162-MUHC

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

simple carbohydrate drink

Experimental group

Description:

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.

Treatment:

Dietary Supplement: simple carbohydrate drink

complex carbohydrate drink

Experimental group

Description:

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.

Treatment:

Dietary Supplement: complex carbohydrate drink