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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02673502
• Date of registration: 28/01/2016
• Prospective Registration: Yes
• Primary sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Public title: Pre-operative Carbohydrate Drink to Preserve Peri-operative Insulin Sensitivity
• Scientific title: Impact of Pre-operative Carbohydrate Drink Provision on Attenuating Peri-operative Insulin Resistant in Major Abdominal Surgery: a Pilot Study
• Date of first enrolment: May 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02673502
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Liane Feldman, MD
• Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre

• Name: Francesco Carli, MD
• Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Laparoscopic Abdominal Surgery

Intervention(s)

Dietary Supplement: complex carbohydrate drink

Dietary Supplement: simple carbohydrate drink

Primary Outcome(s)

difference in insulin resistance [Time Frame: Intra-operative from beginning of surgical procedure until the end of the procedure]

Secondary Outcome(s)

Comparing the preoperative hunger [Time Frame: Two times at 2 weeks before surgery (baseline) and immediately before surgery]

Comparing the preoperative thirst [Time Frame: Two times at 2 weeks before surgery (baseline) and immediately before surgery]

Time to readiness for discharge (TRD) [Time Frame: up to 30 days after surgery]

Grip strength [Time Frame: Two times at 2 weeks before surgery (baseline) and 2 days after surgery]

Postoperative infectious complications [Time Frame: 30 days after operation]

Comparing the Homeostasis model assessment (HOMA) index at four different time points ( by employing Fasting blood sugar and Plasma Insulin) [Time Frame: at 4 time points as follow : on the morning before surgery, first, second and third morning after the surgery]

Comparing the preoperative anxiety [Time Frame: Two times at 2 weeks before surgery (baseline) and immediately before surgery]

Comparing the preoperative well-being [Time Frame: Two times at 2 weeks before surgery (baseline) and immediately before surgery]

Secondary ID(s)

15-162-MUHC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medtronic - MITG

Mitacs