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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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