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

NCT02673502 | Completed

• 1 other identifier: 15-162-MUHC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Abdominal Surgery

Keywords

Carbohydrate drink; Post operative complication; insulin resistance; Fasting blood glucose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• Comparing the preoperative hunger

  Two times at 2 weeks before surgery (baseline) and immediately before surgery

• Comparing the preoperative well-being

  Two times at 2 weeks before surgery (baseline) and immediately before surgery

• Comparing the preoperative anxiety

  Two times at 2 weeks before surgery (baseline) and immediately before surgery

Study Arms (2)

simple carbohydrate drink

EXPERIMENTAL

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

complex carbohydrate drink

EXPERIMENTAL

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

Interventions

simple carbohydrate drink DIETARY_SUPPLEMENT

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.

simple carbohydrate drink

complex carbohydrate drink DIETARY_SUPPLEMENT

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

complex carbohydrate drink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Mitacs: collaborator
• Medtronic - MITG: collaborator

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 4, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

CA (1)