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Laparoscopic Abdominal SurgeryNCT02673502

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

A study testing simple carbohydrate drink and complex carbohydrate drink in people with Laparoscopic Abdominal Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Laparoscopic Abdominal Surgery
What is being tested?
simple carbohydrate drink and complex carbohydrate drink
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
May 2016to May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

Other trials in Canada

About this study

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

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.

Being tested
simple carbohydrate drink, complex carbohydrate drink
Keywords
Carbohydrate drink, Post operative complication, insulin resistance, Fasting blood glucose
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • simple carbohydrate drinkDietary 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.

  • complex carbohydrate drinkDietary 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

Study groups in NCT02673502
Study groupRoleWhat they receive
simple carbohydrate drinkExperimentalPatients 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.
Receives: Dietary Supplement: simple carbohydrate drink
complex carbohydrate drinkExperimentalPatients 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.
Receives: Dietary Supplement: complex carbohydrate drink

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Intra-operative from beginning of surgical procedure until the end of the procedure

Secondary outcomes (8)

  1. Comparing the Homeostasis model assessment (HOMA) index at four different time points ( by employing Fasting blood sugar and Plasma Insulin)

    Measured: at 4 time points as follow : on the morning before surgery, first, second and third morning after the surgery

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. Grip strength

    will be measured by a hand grip dynamometer

    Measured: Two times at 2 weeks before surgery (baseline) and 2 days after surgery

  7. 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.

    Measured: up to 30 days after surgery

  8. Postoperative infectious complications

    Including urinary tract infection, wound infection, intra- or retroperitoneal abscess, pneumonia , sepsis and any other documented infectious complications

    Measured: 30 days after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02673502
Sponsor's protocol ID
15-162-MUHC
Status last verified
Apr 2019
First submitted
28 Jan 2016
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing simple carbohydrate drink and complex carbohydrate drink in people with Laparoscopic Abdominal Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

difference in insulin resistance (time frame: Intra-operative from beginning of surgical procedure until the end of the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02673502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.

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