Clinical trial NCT02673502: Pre-operative Carbohydrate Drink to Preserve Peri-operative Insulin Sensitivity
Official title: Impact of Pre-operative Carbohydrate Drink Provision on Attenuating Peri-operative Insulin Resistant in Major Abdominal Surgery: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Abdominal Surgery
Keywords: Carbohydrate drink
Post operative complication
insulin resistance
Fasting blood glucose
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Mitacs
name: Medtronic - MITG
First posted: 2016-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: difference in insulin resistance
timeFrame: Intra-operative from beginning of surgical procedure until the end of the procedure
Secondary outcomes:
measure: Comparing the Homeostasis model assessment (HOMA) index at four different time points ( by employing Fasting blood sugar and Plasma Insulin)
timeFrame: at 4 time points as follow : on the morning before surgery, first, second and third morning after the surgery
measure: Comparing the preoperative thirst
timeFrame: Two times at 2 weeks before surgery (baseline) and immediately before surgery
measure: Comparing the preoperative hunger
timeFrame: Two times at 2 weeks before surgery (baseline) and immediately before surgery
measure: Comparing the preoperative well-being
timeFrame: Two times at 2 weeks before surgery (baseline) and immediately before surgery
measure: Comparing the preoperative anxiety
timeFrame: Two times at 2 weeks before surgery (baseline) and immediately before surgery
measure: Grip strength
timeFrame: Two times at 2 weeks before surgery (baseline) and 2 days after surgery
measure: Time to readiness for discharge (TRD)
timeFrame: up to 30 days after surgery
measure: Postoperative infectious complications
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Liane Feldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Francesco Carli, MD
role: PRINCIPAL_INVESTIGATOR
References: