Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:54 AM
Study NCT ID:
NCT07483593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Baseline Gastric Volume in Diabetic vs Non-Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative residual gastric volume', 'timeFrame': 'Preoperative period', 'description': 'Assessment of whether standard preoperative fasting guidelines provide an empty stomach in diabetic patients by comparing estimated residual gastric volume measured with gastric ultrasonography between diabetic and non-diabetic patients scheduled for elective surgery'}], 'secondaryOutcomes': [{'measure': 'Association between diabetes severity and gastric volume', 'timeFrame': 'Preoperative assessment', 'description': 'Evaluation of the relationship between diabetes severity and preoperative residual gastric volume.'}, {'measure': 'Baseline gastric volume comparison', 'timeFrame': 'Preoperative assessment', 'description': 'Comparison of baseline gastric volume between diabetic and non-diabetic patients undergoing elective surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Ultrasound', 'Gastric Volume', 'Diabetes Mellitus'], 'conditions': ['Gastric Volume', 'Preoperative Fasting', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'During the preoperative preparation process, the fasting period for anesthesia is planned according to guidelines. According to standard guidelines, a fasting period of at least 2 hours is recommended for clear liquids, at least 6 hours for light meals, and at least 8 hours for a full meal. However, it has been reported that these guidelines are valid for healthy patients. It is thought that the planned fasting periods may vary in diabetic patients due to delayed gastric emptying. This study aims to calculate gastric volume under ultrasonography guidance and compare it with fasting time.', 'detailedDescription': 'Aspiration of gastric contents is the most important risk factor for pulmonary aspiration. Pulmonary aspiration is a serious perioperative complication and can lead to lung damage. The main factor in the development of this complication is the presence of a "full stomach" during induction. This can result from non-compliance with fasting protocols or delayed gastric emptying. Although the incidence of gastric content aspiration is low in patients scheduled for elective surgery, the risk factor is considered increased in diabetic patients due to delayed gastric emptying caused by autonomic dysfunction. Prior to surgery, a bedside ultrasound will be performed on the morning of the operation by an experienced anesthesiologist who is unaware of the patient\'s diabetes mellitus status, using a standard gastric screening protocol. Evaluation of the gastric antrum will be performed by two experienced anesthesiologists using a portable ultrasound device with a convex low-frequency (2-5 MHz) probe, first in the supine position and then in the right lateral decubitus position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of diabetic and non-diabetic adult patients aged 18-75 years, ASA physical status I-III, with BMI ≤40 kg/m2, scheduled for elective surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-75\n* ASA I-III\n* BMI ≤ 40 kg/m2\n\nExclusion Criteria:\n\n* Patients with a history of gastrointestinal surgery,\n* Pregnant women,\n* Patients with documented abnormalities in the upper gastrointestinal tract, such as achalasia'}, 'identificationModule': {'nctId': 'NCT07483593', 'briefTitle': 'Baseline Gastric Volume in Diabetic vs Non-Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Baseline Gastric Volume Measurement in Diabetic and Non-Diabetic Patients: A Non-Inferiority Study', 'orgStudyIdInfo': {'id': 'GOKAEK-2025/14/33'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic patients', 'description': 'Patients with diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume.', 'interventionNames': ['Procedure: Gastric Ultrasound']}, {'label': 'Non-diabetic patients', 'description': 'Patients without diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume.', 'interventionNames': ['Procedure: Gastric Ultrasound']}], 'interventions': [{'name': 'Gastric Ultrasound', 'type': 'PROCEDURE', 'otherNames': ['Preoperative Gastric Ultrasound'], 'description': 'Preoperative gastric ultrasonography will be performed to assess gastric antral cross-sectional area and estimate residual gastric volume in patients scheduled for elective surgery. The examination will be performed in the supine and right lateral decubitus positions using a low-frequency convex probe by experienced anesthesiologists.', 'armGroupLabels': ['Diabetic patients', 'Non-diabetic patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sevim CESUR, MD', 'role': 'CONTACT', 'phone': '+902623038248'}], 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}, {'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Sevim Cesur', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'centralContacts': [{'name': 'Sevim CESUR, MD', 'role': 'CONTACT', 'email': 'svmcsr@gmail.com', 'phone': '+902623038248'}], 'overallOfficials': [{'name': 'Sevim CESUR, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kocaeli University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sevim Cesur', 'investigatorAffiliation': 'Kocaeli University'}}}}