Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT02673502
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2016-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-operative Carbohydrate Drink to Preserve Peri-operative Insulin Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2016-01-28', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference in insulin resistance', 'timeFrame': 'Intra-operative from beginning of surgical procedure until the end of the procedure', 'description': 'intra-operative insulin resistance as assessed by glucose infusion rate required to maintain euglycemic state during a hyperinsulinemic euglycemic glucose clamp'}], 'secondaryOutcomes': [{'measure': 'Comparing the Homeostasis model assessment (HOMA) index at four different time points ( by employing Fasting blood sugar and Plasma Insulin)', 'timeFrame': 'at 4 time points as follow : on the morning before surgery, first, second and third morning after the surgery'}, {'measure': 'Comparing the preoperative thirst', 'timeFrame': 'Two times at 2 weeks before surgery (baseline) and immediately before surgery', 'description': '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.'}, {'measure': 'Comparing the preoperative hunger', 'timeFrame': 'Two times at 2 weeks before surgery (baseline) and immediately before surgery', 'description': '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.'}, {'measure': 'Comparing the preoperative well-being', 'timeFrame': 'Two times at 2 weeks before surgery (baseline) and immediately before surgery', 'description': '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.'}, {'measure': 'Comparing the preoperative anxiety', 'timeFrame': 'Two times at 2 weeks before surgery (baseline) and immediately before surgery', 'description': '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.'}, {'measure': 'Grip strength', 'timeFrame': 'Two times at 2 weeks before surgery (baseline) and 2 days after surgery', 'description': 'will be measured by a hand grip dynamometer'}, {'measure': 'Time to readiness for discharge (TRD)', 'timeFrame': 'up to 30 days after surgery', 'description': '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.'}, {'measure': 'Postoperative infectious complications', 'timeFrame': '30 days after operation', 'description': 'Including urinary tract infection, wound infection, intra- or retroperitoneal abscess, pneumonia , sepsis and any other documented infectious complications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carbohydrate drink', 'Post operative complication', 'insulin resistance', 'Fasting blood glucose'], 'conditions': ['Laparoscopic Abdominal Surgery']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age\n2. Planned laparoscopic partial colon resection for non-metastatic neoplastic or benign disease (including right, transverse, left or sigmoid))\n3. HbA1c less than or equal to 5.7%\n4. Not receiving any kind of glucose lowering medication.\n\nExclusion Criteria:\n\n1. Are already diagnosed with diabetes or pre diabetes (HbA1c \\> 5.7%)\n2. Are pre-diabetic receiving glucose lowering intervention (any glucose lowering medication)\n3. 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)\n4. Will undergo extended resection of adjacent organs\n5. Non-elective operations\n6. New stoma created\n7. Have conditions precluding participation in the ERAS pathway (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)\n8. 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).\n9. 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)\n10. Have received steroids for longer than 30 days\n11. Have poor English or French comprehension.'}, 'identificationModule': {'nctId': 'NCT02673502', 'briefTitle': 'Pre-operative Carbohydrate Drink to Preserve Peri-operative Insulin Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Impact of Pre-operative Carbohydrate Drink Provision on Attenuating Peri-operative Insulin Resistant in Major Abdominal Surgery: a Pilot Study', 'orgStudyIdInfo': {'id': '15-162-MUHC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'simple carbohydrate drink', 'description': '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.', 'interventionNames': ['Dietary Supplement: simple carbohydrate drink']}, {'type': 'EXPERIMENTAL', 'label': 'complex carbohydrate drink', 'description': '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.', 'interventionNames': ['Dietary Supplement: complex carbohydrate drink']}], 'interventions': [{'name': 'simple carbohydrate drink', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['simple carbohydrate drink']}, {'name': 'complex carbohydrate drink', 'type': 'DIETARY_SUPPLEMENT', 'description': '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', 'armGroupLabels': ['complex carbohydrate drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Liane Feldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, {'name': 'Francesco Carli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mitacs', 'class': 'INDUSTRY'}, {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Liane S. Feldman', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}