Pre-operative Carbohydrate Drink to Preserve Peri-operative Insulin Sensitivity
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Dietary Supplement: 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.
|
| Experimental: 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. |
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
|
Outcome Measures
Primary Outcome Measures
- difference in insulin resistance [Intra-operative from beginning of surgical procedure until the end of the procedure]
intra-operative insulin resistance as assessed by glucose infusion rate required to maintain euglycemic state during a hyperinsulinemic euglycemic glucose clamp
Secondary Outcome Measures
- 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 [Two times at 2 weeks before surgery (baseline) and immediately before surgery]
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.
- Comparing the preoperative hunger [Two times at 2 weeks before surgery (baseline) and immediately before surgery]
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.
- Comparing the preoperative well-being [Two times at 2 weeks before surgery (baseline) and immediately before surgery]
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.
- Comparing the preoperative anxiety [Two times at 2 weeks before surgery (baseline) and immediately before surgery]
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.
- Grip strength [Two times at 2 weeks before surgery (baseline) and 2 days after surgery]
will be measured by a hand grip dynamometer
- Time to readiness for discharge (TRD) [up to 30 days after surgery]
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.
- Postoperative infectious complications [30 days after operation]
Including urinary tract infection, wound infection, intra- or retroperitoneal abscess, pneumonia , sepsis and any other documented infectious complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least 18 years of age
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Planned laparoscopic partial colon resection for non-metastatic neoplastic or benign disease (including right, transverse, left or sigmoid))
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HbA1c less than or equal to 5.7%
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Not receiving any kind of glucose lowering medication.
Exclusion Criteria:
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Are already diagnosed with diabetes or pre diabetes (HbA1c > 5.7%)
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Are pre-diabetic receiving glucose lowering intervention (any glucose lowering medication)
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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)
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Will undergo extended resection of adjacent organs
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Non-elective operations
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New stoma created
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Have conditions precluding participation in the ERAS pathway (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
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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).
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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)
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Have received steroids for longer than 30 days
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Have poor English or French comprehension.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montreal General Hospital | Montreal | Quebec | Canada | H3G 1A4 |
Sponsors and Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Mitacs
- Medtronic - MITG
Investigators
- Principal Investigator: Liane Feldman, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Principal Investigator: Francesco Carli, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15-162-MUHC