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

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Pre-operative Carbohydrate Drink Provision on Attenuating Peri-operative Insulin Resistant in Major Abdominal Surgery: a Pilot Study

Conditions
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Laparoscopic Abdominal Surgery

Intervention / Treatment
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* Dietary Supplement: simple carbohydrate drink
* Dietary Supplement: complex carbohydrate drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Planned laparoscopic partial colon resection for non-metastatic neoplastic or benign disease (including right, transverse, left or sigmoid)) HbA1c less than or equal to 5.7% Not receiving any kind of glucose lowering medication. Exclusion Criteria: Are already diagnosed with diabetes or pre diabetes (HbA1c > 5.7%) Are pre-diabetic receiving glucose lowering intervention (any glucose lowering medication) 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) Will undergo extended resection of adjacent organs Non-elective operations New stoma created Have conditions precluding participation in the ERAS pathway (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis) 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). 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) Have received steroids for longer than 30 days Have poor English or French comprehension.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simple carbohydrate drink<br>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. | Dietary Supplement: simple carbohydrate drink<br>* 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.<br>|
| Experimental: complex carbohydrate drink<br>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. | Dietary Supplement: complex carbohydrate drink<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in insulin resistance | intra-operative insulin resistance as assessed by glucose infusion rate required to maintain euglycemic state during a hyperinsulinemic euglycemic glucose clamp | Intra-operative from beginning of surgical procedure until the end of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the Homeostasis model assessment (HOMA) index at four different time points ( by employing Fasting blood sugar and Plasma Insulin) |  | at 4 time points as follow : on the morning before surgery, first, second and third morning after the surgery | 
| Comparing the preoperative thirst | Patients will complete a standard 10mm visual analogue scale (VAS) for each of the measures by marking the level on the scale at baseline in the pre-op clinic visit and once more immediately before surgery. | Two times at 2 weeks before surgery (baseline) and immediately before surgery | 
| Comparing the preoperative hunger | Patients will complete a standard 10mm visual analogue scale (VAS) for each of the measures by marking the level on the scale at baseline in the pre-op clinic visit and once more immediately before surgery. | Two times at 2 weeks before surgery (baseline) and immediately before surgery | 
| Comparing the preoperative well-being | Patients will complete a standard 10mm visual analogue scale (VAS) for each of the measures by marking the level on the scale at baseline in the pre-op clinic visit and once more immediately before surgery. | Two times at 2 weeks before surgery (baseline) and immediately before surgery | 
| Comparing the preoperative anxiety | Patients will complete a standard 10mm visual analogue scale (VAS) for each of the measures by marking the level on the scale at baseline in the pre-op clinic visit and once more immediately before surgery. | Two times at 2 weeks before surgery (baseline) and immediately before surgery | 
| Grip strength | will be measured by a hand grip dynamometer | Two times at 2 weeks before surgery (baseline) and 2 days after surgery | 
| Time to readiness for discharge (TRD) | Previously described criteria to determine the time to readiness for discharge after colorectal surgery will be used . These criteria include tolerance of oral intake, recovery of lower gastro intestinal function, achieving adequate pain control, ability to mobilize and perform self-care and clinical/lab results showing no complications or untreated medical problems. | up to 30 days after surgery | 
| Postoperative infectious complications | Including urinary tract infection, wound infection, intra- or retroperitoneal abscess, pneumonia , sepsis and any other documented infectious complications | 30 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbohydrate drink, Post operative complication, insulin resistance, Fasting blood glucose