Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT05494658
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2022-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Preoperative Oral Branched-chain Amino Acids on Reducing Postoperative Insulin Resistance.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-08-07', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of postoperative blood glucose>8mmol/L', 'timeFrame': '1 day', 'description': 'The proportion of postoperative blood glucose\\>8mmol/L.Measure method：Continuous blood glucose meter.'}], 'secondaryOutcomes': [{'measure': 'Postoperative blood glucose', 'timeFrame': '1 day', 'description': 'Measured by continuous blood glucose meter'}, {'measure': 'Homeostasis model assessment - insulin resistance （HOMA-IR）', 'timeFrame': '1 day', 'description': 'Measured by blood test. HOMA-IR = (blood glucose \\[mmol/L\\] × blood insulin \\[μunits/mL\\])/22.5.'}, {'measure': 'Postoperative complications', 'timeFrame': '1 month', 'description': 'Postoperative complications include branched-chain amino acid-related complications, surgery-related complications, and systemic complications. Postoperative complications were graded according to the Clavien-Dindo system'}, {'measure': 'Postoperative hospital stay', 'timeFrame': '1 month', 'description': 'Postoperative hospital stay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative insulin resistance', 'branched chain amino acids', 'colorectal cancer'], 'conditions': ['Insulin Resistance', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': "Postoperative insulin resistance refers to the phenomenon that the body's glucose uptake stimulated by insulin is reduced due to stress effects such as trauma or the inhibitory effect of insulin on liver glucose output is weakened after surgery.\n\nThere is a clear link between postoperative insulin resistance and poor perioperative prognosis. Therefore, exploring interventions to reduce postoperative stress insulin resistance, stabilize postoperative blood glucose, and reduce postoperative complications are clinical problems that need to be solved urgently. In recent years, research on branched-chain amino acids and metabolic diseases has become a hot spot. Studies have found that in the rat model, preoperatively given a high branched-chain amino acid diet can inhibit postoperative insulin resistance and stabilize blood glucose levels. This research plan is to try to add branched-chain amino acids before surgery to observe the occurrence of postoperative insulin resistance in patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 50-80 years old ;\n2. Clinical diagnosis of colorectal cancer;\n3. Planned elective laparoscopic radical resection of colorectal cancer;\n4. Preoperative American Society of Anesthesiologists（ASA）score grade I-III ;\n5. Informed consent was obtained from patients.\n\nExclusion Criteria:\n\n1. Clinical diagnosis of Diabetes mellitus;\n2. Preoperative insulin resistance ;\n3. Renal insufficiency requires dialysis, hepatic insufficiency (Child - Pugh grade B and above);\n4. Eating disorders caused by gastrointestinal obstruction;\n5. Pregnant or lactating women;\n6. Patients with severe mental illness.'}, 'identificationModule': {'nctId': 'NCT05494658', 'briefTitle': 'Impact of Preoperative Oral Branched-chain Amino Acids on Reducing Postoperative Insulin Resistance.', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Tong Ren Hospital'}, 'officialTitle': 'A Multicenter Randomized Controlled Study of Preoperative Oral Administration of Branched-chain Amino Acids in Reducing Postoperative Insulin Resistance in Colorectal Cancer Patients', 'orgStudyIdInfo': {'id': '2022-050-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'research group', 'description': '600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.', 'interventionNames': ['Dietary Supplement: BCAA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': '600ml water was consumed by patients 2-4h before suegery.', 'interventionNames': ['Dietary Supplement: water']}], 'interventions': [{'name': 'BCAA', 'type': 'DIETARY_SUPPLEMENT', 'description': '600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.', 'armGroupLabels': ['research group']}, {'name': 'water', 'type': 'DIETARY_SUPPLEMENT', 'description': '600ml water was consumed by patients 2-4h before suegery.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Sun', 'role': 'CONTACT', 'email': 'SP2082@shtrhospital.com', 'phone': '+86-18121225835'}], 'facility': 'Shanghai Tongren Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Peng Sun, MD', 'role': 'CONTACT', 'email': 'SP2082@shtrhospital.com', 'phone': '+86-18121225835'}, {'name': 'Hengyu Lv', 'role': 'CONTACT', 'email': 'LHY4624@shtrhospital.com', 'phone': '+86-18006315921'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Peng', 'class': 'OTHER'}, 'collaborators': [{'name': 'Huashan Hospital', 'class': 'OTHER'}, {'name': 'Yangpu District Central Hospital Affiliated to Tongji University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Executive Director of General Surgery', 'investigatorFullName': 'Sun Peng', 'investigatorAffiliation': 'Shanghai Tong Ren Hospital'}}}}