Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 10:54 AM
Study NCT ID:
NCT04013594
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2019-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Oral Carbohydrates on the Glycemic Variability of Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-23', 'studyFirstSubmitDate': '2019-06-26', 'studyFirstSubmitQcDate': '2019-07-03', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic variability', 'timeFrame': 'Before anesthesia', 'description': '\\- Coefficient of glucose variability =SD/mean x 100 (%)'}, {'measure': 'Glycemic variability', 'timeFrame': 'Before anesthesia', 'description': '\\- J index=0.001 x (MBG +SD)2 mg/dL'}, {'measure': 'Glycemic variability', 'timeFrame': 'immediately after anesthesia', 'description': '\\- Coefficient of glucose variability =SD/mean x 100 (%)'}, {'measure': 'Glycemic variability', 'timeFrame': 'immediately after anesthesia', 'description': '\\- J index=0.001 x (MBG +SD)2 mg/dL'}, {'measure': 'Glycemic variability', 'timeFrame': 'operation end', 'description': '\\- Coefficient of glucose variability =SD/mean x 100 (%)'}, {'measure': 'Glycemic variability', 'timeFrame': 'operation end', 'description': '\\- J index=0.001 x (MBG +SD)2 mg/dL'}, {'measure': 'Glycemic variability', 'timeFrame': '1 hour after surgery', 'description': '\\- Coefficient of glucose variability =SD/mean x 100 (%)'}, {'measure': 'Glycemic variability', 'timeFrame': '1 hour after surgery', 'description': '\\- J index=0.001 x (MBG +SD)2 mg/dL'}], 'secondaryOutcomes': [{'measure': 'Insulin resistance', 'timeFrame': 'Before anesthesia', 'description': 'Insulin resistance index = fasting glucose x fasting insulin/22.5'}, {'measure': 'Insulin resistance', 'timeFrame': 'Before anesthesia', 'description': 'serum laboratory test: glucagon'}, {'measure': 'Insulin resistance', 'timeFrame': 'Before anesthesia', 'description': 'serum laboratory test: GLP-1'}, {'measure': 'Insulin resistance', 'timeFrame': 'Before anesthesia', 'description': 'serum laboratory test: C-peptide'}, {'measure': 'Insulin resistance', 'timeFrame': 'Before anesthesia', 'description': 'serum laboratory test: free fatty acid'}, {'measure': 'gastric volume', 'timeFrame': 'Before anesthesia', 'description': 'gastric volume measured by ultrasonography.'}, {'measure': 'hand grip strength', 'timeFrame': 'Before anesthesia', 'description': 'hand grip strength measured by electronic hand dynamometer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '11254464', 'type': 'BACKGROUND', 'citation': 'Soop M, Nygren J, Myrenfors P, Thorell A, Ljungqvist O. Preoperative oral carbohydrate treatment attenuates immediate postoperative insulin resistance. Am J Physiol Endocrinol Metab. 2001 Apr;280(4):E576-83. doi: 10.1152/ajpendo.2001.280.4.E576.'}, {'pmid': '18331374', 'type': 'BACKGROUND', 'citation': 'Gustafsson UO, Nygren J, Thorell A, Soop M, Hellstrom PM, Ljungqvist O, Hagstrom-Toft E. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008 Aug;52(7):946-51. doi: 10.1111/j.1399-6576.2008.01599.x. Epub 2008 Mar 7.'}, {'pmid': '35006328', 'type': 'DERIVED', 'citation': 'Lee B, Kim SY, Cho BW, Suh S, Park KK, Choi YS. Preoperative Carbohydrate Drink Intake Increases Glycemic Variability in Patients with Type 2 Diabetes Mellitus in Total Joint Arthroplasty: A Prospective Randomized Trial. World J Surg. 2022 Apr;46(4):791-799. doi: 10.1007/s00268-021-06437-1. Epub 2022 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'Preoperative carbohydrate drink intake attenuate insulin resistance. However, carbohydrate loading may compromise blood glucose control in patients with diabetes. There is some evidence that oral carbohydrate loading may be safe in patients with type 2 diabetes. Therefore, the investigators aim to evaluate whether preoperative carbohydrate intake affects insulin resistance and glycemic variability in patients with diabetes. Fifty patients scheduled for total knee arthroplasty will be divided into carbohydrate (n=25) and control (n=25) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage 2-3 hours before their scheduled operation. In contrast, patients in the control group are fasted from water 2 hours before surgery according to standard protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Patients undergoing total knee arthroplasty\n\nExclusion Criteria:\n\n* 1\\. Patients with contraindications to spinal anesthesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)\n* 2\\. Patients with gastroesophageal reflux disease, gastric emptying disorders, inflammatory bowel disease, or previous treatment for intra-abdominal cancer\n* 3\\. Patients with chronic renal disease or severe cardiovascular disease\n* 4\\. HbA1c \\>69 mmol/mol or BMI \\>30 kg/m2\n* 5\\. A duration of ≥5 hours between consumption of CHO and initiation of surgery.\n* 6\\. The subject is a foreigner or illiterate'}, 'identificationModule': {'nctId': 'NCT04013594', 'briefTitle': 'Effect of Preoperative Oral Carbohydrates on the Glycemic Variability of Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Preoperative Oral Carbohydrates on the Glycemic Variability of Diabetic Patients', 'orgStudyIdInfo': {'id': '4-2019-0428'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'carbohydrate group(CHO group)', 'interventionNames': ['Dietary Supplement: carbohydrate group']}, {'type': 'NO_INTERVENTION', 'label': 'control group'}], 'interventions': [{'name': 'carbohydrate group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Randomly selected patients of the carbohydrate group are given oral carbohydrate (400ml) 2-3 hours before surgery.', 'armGroupLabels': ['carbohydrate group(CHO group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}