Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT06581120
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-11-07
First Post:
2024-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GLP_1 RA Ultrasound Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097789', 'term': 'Glucagon-Like Peptide-1 Receptor Agonists'}], 'ancestors': [{'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-08-29', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aspiration Risk determined by POGUS', 'timeFrame': 'Two years', 'description': 'Difference between control group and GLP-1 group. Measured by Gastric contents during Point of Care Gastric Ultrasound.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GLP-1', 'Glucagon like Peptide 1', 'Aspiration', 'Gastric empty'], 'conditions': ['Glucagon Like Peptide-1 (GLP-1', 'Delayed Gastric Emptying', 'Risk of Aspiration', 'Diabetes', 'Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether patients taking GLP-1 RAs have increased residual (left behind), gastric (stomach), contents due to delayed gastric emptying when following standard preoperative fasting guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited from the endocrine clinic and from the preoperative surgical schedule.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index over 35\n* Type 2 Diabetes\n* Currently taking GLP01 RA agonist (for GLP 1 group)\n* Not taking GLP-1 RA agonist (for control group)\n\nExclusion Criteria:\n\n* Diagnosis of gastroparesis\n* patient refusal to participate\n* Previous gastric bypass or any other gastric surgery\n* Currently on peritoneal dialysis\n* Abdominal pathology\n* Gastro-intestinal obstruction\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06581120', 'briefTitle': 'GLP_1 RA Ultrasound Study', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Assessment of Gastric Contents in Patients Taking Glucagon-Like Peptide-1 Receptor Agonists: a Prospective Observational Cross-sectional Study', 'orgStudyIdInfo': {'id': '2024-0304'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GLP-1', 'description': "Individuals currently taking glucagon like peptide receptors who have a surgery scheduled with Cincinnati Children's Hospital same day surgery endocrinology clinic and will receive a point of care gastric ultrasound.", 'interventionNames': ['Drug: Glucagon-Like Peptide-1 receptor agonists', 'Diagnostic Test: Point of Care Gastric Ultrasound']}, {'label': 'Control', 'description': "Individuals not taking GLP-1 who have a surgery scheduled with Cincinnati Children's Hospital same day surgery or endocrinology clinic and will receive a point of care gastric ultrasound.", 'interventionNames': ['Diagnostic Test: Point of Care Gastric Ultrasound']}], 'interventions': [{'name': 'Glucagon-Like Peptide-1 receptor agonists', 'type': 'DRUG', 'description': 'GLP-1 RAs: Glucagon like peptide-1 receptor agonists, this includes patients who are on Liraglutide, Semaglutide, Dulaglutide and Tirzepatide.Tirzepatide which is a combined GLP-1 RA/glucose-dependent insulinotropic polypeptide (GIP) agonist is included as a part of GLP-1 RAs.', 'armGroupLabels': ['GLP-1']}, {'name': 'Point of Care Gastric Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['POGUS'], 'description': 'A gastric ultrasound following a standard NPO period to determine gastric contents and risk of aspiration during surgery.', 'armGroupLabels': ['Control', 'GLP-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45299', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}