Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 35 of 98 for:    grams | maltodextrin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673502
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : April 11, 2019
Sponsor:
Collaborators:
Mitacs
Medtronic - MITG
Information provided by (Responsible Party):
Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease Intervention/treatment Phase
Laparoscopic Abdominal Surgery Dietary Supplement: simple carbohydrate drink Dietary Supplement: complex carbohydrate drink Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Pre-operative Carbohydrate Drink Provision on Attenuating Peri-operative Insulin Resistant in Major Abdominal Surgery: a Pilot Study
Study Start Date : May 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: 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.
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.

Experimental: 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.
Dietary Supplement: 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




Primary Outcome Measures :
  1. difference in insulin resistance [ Time Frame: Intra-operative from beginning of surgical procedure until the end of the procedure ]
    intra-operative insulin resistance as assessed by glucose infusion rate required to maintain euglycemic state during a hyperinsulinemic euglycemic glucose clamp


Secondary Outcome Measures :
  1. 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 ]
  2. Comparing the preoperative thirst [ Time Frame: Two times at 2 weeks before surgery (baseline) and immediately before surgery ]
    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.

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

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

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

  6. Grip strength [ Time Frame: Two times at 2 weeks before surgery (baseline) and 2 days after surgery ]
    will be measured by a hand grip dynamometer

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

  8. Postoperative infectious complications [ Time Frame: 30 days after operation ]
    Including urinary tract infection, wound infection, intra- or retroperitoneal abscess, pneumonia , sepsis and any other documented infectious complications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673502


Locations
Layout table for location information
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Mitacs
Medtronic - MITG
Investigators
Layout table for investigator information
Principal Investigator: 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

Layout table for additonal information
Responsible Party: Dr. Liane S. Feldman, Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02673502     History of Changes
Other Study ID Numbers: 15-162-MUHC
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Keywords provided by Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Carbohydrate drink
Post operative complication
insulin resistance
Fasting blood glucose
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs