Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT05142657
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2021-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Are There Dietary Factors Affecting the Development of Pancreatitis in Patients With Gallstones?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D042882', 'term': 'Gallstones'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'C564245', 'term': 'Platelet Glycoprotein IV Deficiency'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004034', 'term': 'Diet Surveys'}], 'ancestors': [{'id': 'D009749', 'term': 'Nutrition Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2021-11-21', 'studyFirstSubmitQcDate': '2021-11-21', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'energy, cholesterol, protein, fat', 'timeFrame': '3 days', 'description': 'Daily energy, cholesterol, protein, fat intake of the participants'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['meat', 'egg', 'fat', 'protein'], 'conditions': ['Diet Habit', 'Gall Stone', 'Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '27609706', 'type': 'BACKGROUND', 'citation': 'Setiawan VW, Pandol SJ, Porcel J, Wei PC, Wilkens LR, Le Marchand L, Pike MC, Monroe KR. Dietary Factors Reduce Risk of Acute Pancreatitis in a Large Multiethnic Cohort. Clin Gastroenterol Hepatol. 2017 Feb;15(2):257-265.e3. doi: 10.1016/j.cgh.2016.08.038. Epub 2016 Sep 5.'}, {'pmid': '30569031', 'type': 'BACKGROUND', 'citation': "Dugum M, Gougol A, Paragomi P, Gao X, Matta B, Yazici C, Tang G, Greer P, Pothoulakis I, O'Keefe SJD, Whitcomb DC, Yadav D, Papachristou GI. Association of Dietary Habits with Severity of Acute Pancreatitis. Curr Dev Nutr. 2018 Oct 8;2(12):nzy075. doi: 10.1093/cdn/nzy075. eCollection 2018 Dec."}]}, 'descriptionModule': {'briefSummary': 'The most common cause of acute pancreatitis is gallstones. It is known that diet and obesity play a role in the formation of gallstones. It has been reported that the risk of gallstone formation is two times higher in obese individuals with a body mass index (BMI) \\>30 than in normal-weight individuals with a BMI between 20-25. The epidemiological literature on the relationship between diet and risk of acute pancreatitis is very limited. In addition, it is often unclear which type (acute, recurrent, or chronic) and subtype (gallstone-related or non-gallstone-related) of acute pancreatitis is studied in studies. Although there are studies in the literature evaluating the relationship between diet and development of gallstones or the development of pancreatitis with diet, studies examining the role of diet in the development of pancreatitis in patients with gallstones are very limited. In this study, we aimed to investigate the dietary differences in patients with gallstones who had pancreatitis and those who did not.', 'detailedDescription': 'The incidence of acute pancreatitis has been reported as 4.9-35/100.000, and the incidence increases every year with the increase in obesity and gallstone rates. It is most commonly observed between the ages of 30-60 and no difference was found in terms of gender distribution. The most common cause of acute pancreatitis is gallstones. Alcohol use, drugs and other reasons come next.\n\nIt is known that diet and obesity play a role in the formation of gallstones. It has been reported that the risk of gallstone formation is two times higher in obese individuals with a body mass index (BMI) \\>30 than in normal-weight individuals with a BMI between 20-25. In addition, many studies have reported that increased use of dietary refined carbohydrates and triglycerides and reduced dietary fiber intake are associated with gallstone formation.\n\nThe epidemiological literature on the relationship between diet and risk of acute pancreatitis is very limited. In addition, it is often unclear which type (acute, recurrent, or chronic) and subtype (gallstone-related or non-gallstone-related) of acute pancreatitis is studied in studies. On the other hand, Sarles et al. In a comprehensive study conducted in 1973, he reported that high fat and protein consumption and alcoholism increase the risk of pancreatitis, regardless of etiology. Few case-control and ecological studies have evaluated the effect of protein, fat, and carbohydrate intakes on alcohol-related or gallstone-related acute pancreatitis risk or non-gallstone-related acute pancreatitis risk or acute pancreatitis mortality.\n\nAt the beginning of the twentieth century, an inverse relationship between coffee consumption and the risk of alcohol-induced acute pancreatitis was observed in a prospective study, and an inverse relationship with fruit consumption in two smaller case-control studies, and a positive association with consumption of freshwater fish and parboiled rice. In parallel, overly large meals and food allergies after a long period of fasting have been reported to be risk factors for acute pancreatitis.\n\nAlthough there are studies in the literature evaluating the relationship between diet and development of gallstones or the development of pancreatitis with diet, studies examining the role of diet in the development of pancreatitis in patients with gallstones are very limited. In this study, we aimed to investigate the dietary differences in patients with gallstones who had pancreatitis and those who did not.\n\nIn the study, age, gender, body mass index, alcohol and cigarette consumption status, daily physical activity status, eating frequency, frequency of food consumption for three days, and their food consumption status will be evaluated with the BeBis 8 Full version program and it will be compared whether there is a difference between patients who had pancreatitis and those who did not. .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the participants have gallstone. In control group participants did not have any pancreatitis history. In case group patients have pancreatitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria in the pancreatitis group were :\n\n* 18-80 years of age,\n* having gallbladder stones\n* being diagnosed with pancreatitis, exclusion criteria in the pancreatitis group were:\n* having any cancer,\n* being pregnant,\n* having chronic liver or kidney disease,\n* icterus,\n* developing after ERCP.\n\nInclusion criteria in the control group were:\n\n* 18-80 years of age\n* gallbladder stones, exclusion criteria in the control group were:\n* any cancer,\n* pregnancy,\n* chronic liver or kidney disease,\n* icterus,\n* previous pancreatitis attack'}, 'identificationModule': {'nctId': 'NCT05142657', 'briefTitle': 'Are There Dietary Factors Affecting the Development of Pancreatitis in Patients With Gallstones?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Training and Research Hospital'}, 'officialTitle': 'Are There Dietary Factors Affecting the Development of Pancreatitis in Patients With Gallstones?', 'orgStudyIdInfo': {'id': 'Pancreatitis diet'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': 'Patients who have gallstone pancreatitis', 'interventionNames': ['Other: diet survey']}, {'label': 'Control', 'description': 'Patients who have only gallstone', 'interventionNames': ['Other: diet survey']}], 'interventions': [{'name': 'diet survey', 'type': 'OTHER', 'description': 'Dietary survey applied to all participants', 'armGroupLabels': ['Case', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34371', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Traininng and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ufuk O İdiz, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. MD. PhD', 'investigatorFullName': 'Ufuk Oguz Idiz', 'investigatorAffiliation': 'Istanbul Training and Research Hospital'}}}}