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

Laparoscopic Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673502
• Other study ID #: 15-162-MUHC
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: April 2019
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Abdominal Surgery

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Center	Medtronic - MITG, Mitacs

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Grip strength	will be measured by a hand grip dynamometer	Two times at 2 weeks before surgery (baseline) and 2 days after surgery
Secondary	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
Secondary	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