Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-02 @ 2:41 AM
Study NCT ID:
NCT04456166
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2020-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Preoperative Carbohydrate Loading in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562602', 'term': 'Glucose-Galactose Malabsorption'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of gastric ultrasonography score as low risk (grade 0 or 1)', 'timeFrame': '30 minutes after intubation', 'description': 'Ultrasound assessment of gastric volume by gastroscopic examination.'}], 'secondaryOutcomes': [{'measure': 'Gastric volume', 'timeFrame': '30 minutes after intubation'}, {'measure': 'Blood sugar test', 'timeFrame': '30 minutes after intubation and 30 minutes after extubation'}, {'measure': 'The incidence of insulin bolus injection', 'timeFrame': 'during operation'}, {'measure': 'The incidence of insulin bolus injection', 'timeFrame': 'up to 30 minutes after extubation'}, {'measure': 'Satisfaction scale of patients', 'timeFrame': 'up to 30 minutes after extubation'}, {'measure': 'The incidence of nausea and vomiting', 'timeFrame': 'up to 30 minutes after extubation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carbohydrate Intolerance', 'Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Carbohydrate loading'], 'conditions': ['Carbohydrate Intolerance', 'Diabetes Mellitus Type 2']}, 'referencesModule': {'references': [{'pmid': '36266449', 'type': 'DERIVED', 'citation': 'Lee S, Sohn JY, Lee HJ, Yoon S, Bahk JH, Kim BR. Effect of pre-operative carbohydrate loading on aspiration risk evaluated with ultrasonography in type 2 diabetes patients: a prospective observational pilot study. Sci Rep. 2022 Oct 20;12(1):17521. doi: 10.1038/s41598-022-21696-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety of preoperative carbohydrate loading in diabetic patients undergoing general anesthesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years of age who are scheduled to undergo general anesthesia are subject to preoperative carbohydrodritate loading and diagnosed with type 2 diabetes taking oral hypoglycemic agents', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Elective surgery\n* Type 2 diabetes mellitus on oral hypoglycemic agents\n* American Society of Anesthesiologists physical status 2 or 3\n* Ages 18 or more\n* Approve to participate\n\nExclusion Criteria:\n\n* Ambulatory surgery\n* BMI \\>35\n* History of gastric or esophagus surgery\n* History of GERD, dyspepesia or\n* Anticipated difficult intubation (previous III or more Cormack and Lehane's grade, Mallamgrade, Mallampati scpati scoreore III or moreIII or more, propro/retro/retrognathism, gnathism, thyromental distance\\<6.5cm, thyromental distance\\<6.5cm, limited mouth openinglimited mouth opening)"}, 'identificationModule': {'nctId': 'NCT04456166', 'acronym': 'NoNPO', 'briefTitle': 'Safety of Preoperative Carbohydrate Loading in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Safety of Preoperative Carbohydrate Loading in Diabetic Patients Undergoing General Anesthesia', 'orgStudyIdInfo': {'id': '20030471108'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient who received carbohydrate loading', 'description': 'Patients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting', 'interventionNames': ['Dietary Supplement: noNPO']}], 'interventions': [{'name': 'noNPO', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting will be asked to be enrolled into the study.\n\nBefore induction of general anesthesia, all patients were evaluated the gastric volume under ultrasonography.', 'armGroupLabels': ['Patient who received carbohydrate loading']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Jongnogu', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Susie Yoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Susie Yoon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}