Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-30 @ 10:11 PM
Study NCT ID:
NCT06987669
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-23
First Post:
2025-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Emptying in Healthy Volunteers and GLP-1 Agonist Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with each Grade ( stomach content characteristics) according Perlas et al', 'timeFrame': '24 hours tops since the starting of the clear fluid diet', 'description': 'Grade 0 ( empty in supine and RLD), Grade 1 ( empty supine but liquid content on RDL), Grade 3 ( Solid content or fluid with an area of more than or equal to 10 cm2).'}], 'secondaryOutcomes': [{'measure': 'Area of the stomach in supine and in RLD assessed by ultrasound', 'timeFrame': '24 hours tops since the starting of the clear fluid diet', 'description': 'Grade 0 ( empty in supine and RLD), Grade 1 ( empty supine but liquid content on RDL), Grade 3 ( Solid content or fluid with an area of more than or equal to 10 cm2).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['agonist GLP-1', 'perioperative fasting'], 'conditions': ['Diabetes Type 2', 'Obesity and Overweight']}, 'descriptionModule': {'briefSummary': 'This observational study aims to determine the gastric emptying kinetics assessed by ultrasound in healthy volunteers after a standard breakfast and the state of the stomach after a clear liquid diet for 18 /24 hours in patients on GLP-1 agonist. The main questions it seeks to answer are:\n\n* Is the kinetic after a standard breakfast that includes ( avocado and eggs: high fat) as fast as a standard meal that does not involve this food?\n* Is a clear liquid diet of 18 to 24 hours enough to be an empty-stomach, assessed by Ultrasound in patients on GLP1 agonist?\n\nParticipants will be asked to do:\n\n-A baseline Gastric US will be performed for healthy volunteers, and then they will have a standardized breakfast. An hourly or bihourly assessment will be done by the US.', 'detailedDescription': 'GLP-1 analogues enhance insulin secretion from β-cells, reduce glucagon secretion, have an appetite-suppressing effect, and delay gastric emptying. This last effect may make standard preoperative fasting inadequate, compromising airway safety during elective surgery and increasing aspiration risk.\n\nThe main goal is to gather evidence to determine the optimal fasting period and dietary regimen to ensure safe outpatient surgery without increasing the risk of aspiration.Ultrasound gastric content assessment is a highly accessible, bedside, cost-free, and low-risk tool for anesthesiologists. The increased use of these drugs in surgical patients and the lack of international consensus on their discontinuation and fasting protocols before surgery necessitate further study. Our hypothesis is that GLP-1 analogue users (for weight loss or diabetes) have significantly slower gastric emptying, but a 24-hour liquid regimen may be sufficient to ensure an empty stomach and safe elective surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers will be assessed for emptying the stomach after a standardized high-fat meal, by ultrasound.\n\nCohort of patients on a GLP-1 agonist after 18/24 hours of clear fluids.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older\n* Healthy volunteers or semaglutide users\n\nExclusion Criteria:\n\n* Bariatric surgery\n* Hiatal hernia\n* Impairment to give consent'}, 'identificationModule': {'nctId': 'NCT06987669', 'acronym': 'aGLP1-GUS', 'briefTitle': 'Gastric Emptying in Healthy Volunteers and GLP-1 Agonist Users', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Alemana de Santiago'}, 'officialTitle': 'Gastric Emptying Assessed by Gastric Ultrasound (US) in Healthy Volunteers and Semaglutide Users: Cohort Study', 'orgStudyIdInfo': {'id': 'ID1406'}, 'secondaryIdInfos': [{'id': '2024-100', 'type': 'OTHER', 'domain': 'Comité Etico Cientifico Facultad de Medicina Universidad del Desarrollo Clínica Alemana'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers after high fat standardized breakfast', 'description': 'GUS will be made', 'interventionNames': ['Diagnostic Test: Gastric Ultrasound']}, {'label': 'Patients on GLP-1 agonist', 'description': 'Patients on GLP-1 agonist after clear fluids diet of 18/24 hrs. GUS will be made.', 'interventionNames': ['Diagnostic Test: Gastric Ultrasound']}], 'interventions': [{'name': 'Gastric Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['GUS'], 'description': 'A gastric ultrasound will be performed to determine the state of the stomach. Empty, clear fluids, solid, and in case of fluid, the amount of it ( using free tracing)', 'armGroupLabels': ['Healthy volunteers after high fat standardized breakfast', 'Patients on GLP-1 agonist']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Javiera Vargas, MD, MSc', 'role': 'CONTACT', 'email': 'jpvargasz@gmail.com', 'phone': '+56957383772'}], 'overallOfficials': [{'name': 'Cristian Arzola, MD, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad de Toronto'}, {'name': 'Juan Pablo Ghiringelli', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Valparaiso'}, {'name': 'Miguel vega, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad del Desarrollo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Alemana de Santiago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Javiera Vargas', 'investigatorAffiliation': 'Clinica Alemana de Santiago'}}}}