[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100420958":3},{"organization":4,"outcomesModule":7,"designInfo":118,"detailedDescription":128,"studyPopulation":117,"armGroups":129,"interventions":141,"overallOfficials":151,"centralContacts":156,"locations":165,"responsibleParty":181,"collaborators":117,"id":185,"slug":117,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":186,"sex":192,"minAge":193,"maxAge":117,"enrollmentInfo":194,"targetDuration":117,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":168,"whyStopped":117,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"fullName":5,"class":6},"University of Pecs","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":117},[9],{"measure":10,"description":11,"timeFrame":12},"Occurrence of recurrent acute pancreatitis and\u002For all-cause mortality","The recurrence of acute pancreatitis (given as a rate of event) AND\u002FOR all-cause mortality.","Data will be recorded during the 3-6-12-18-24 months followup visits",[14,17,20,23,27,30,34,37,40,43,46,49,52,55,58,61,64,66,69,72,75,78,81,84,87,90,93,96,99,102,105,108,111,114],{"measure":15,"description":16,"timeFrame":12},"Proportion of pancreas specific mortality","Mortality of a pancreatic cause",{"measure":18,"description":19,"timeFrame":12},"Proportion of cardiosvascular cause mortality","Mortality of a cardiovascular cause.",{"measure":21,"description":22,"timeFrame":12},"Proportion of newly diagnosed chronic pancreatitis patients","Newly diagnosed chronic pancreatitis.",{"measure":24,"description":25,"timeFrame":26},"Changes in BMI","Changes in BMI compared to baseline both in total and percentage","Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits",{"measure":28,"description":29,"timeFrame":12},"Serum total cholesterol","Serum total cholesterol absolute value",{"measure":31,"description":32,"timeFrame":33},"Change in serum total cholesterol","Serum total cholesterol compared to baseline","Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits",{"measure":35,"description":36,"timeFrame":12},"Serum triglyceride","Serum triglyceride absolute value",{"measure":38,"description":39,"timeFrame":33},"Change in serum triglyceride","Serum triglyceride compared to baseline",{"measure":41,"description":42,"timeFrame":12},"Serum high density liporpotein(HDL)-cholesterol","Serum high density liporpotein(HDL)-cholesterol absolute value",{"measure":44,"description":45,"timeFrame":33},"Change in serum high density liporpotein(HDL)-cholesterol","Serum high density liporpotein(HDL)-cholesterol compared to baseline",{"measure":47,"description":48,"timeFrame":12},"Serum low density liporpotein(LDL)-cholesterol","Serum low density liporpotein(LDL)-cholesterol absolute value",{"measure":50,"description":51,"timeFrame":33},"Change in serum low density liporpotein(LDL)-cholesterol","Serum low density liporpotein(LDL)-cholesterol compared to baseline",{"measure":53,"description":54,"timeFrame":12},"Systolic blood pressure value","Systolic blood pressure absolute value",{"measure":56,"description":57,"timeFrame":26},"Change in systolic blood pressure","Systolic blood pressure compared to baseline",{"measure":59,"description":60,"timeFrame":12},"Diastolic blood pressure","Diastolic blood pressure absolute value",{"measure":62,"description":63,"timeFrame":33},"Change in siastolic blood pressure","Diastolic blood pressure compared to baseline",{"measure":65,"description":65,"timeFrame":12},"Adherence to dietary recommendations as determined by the result of the food frequency questionnaire",{"measure":67,"description":68,"timeFrame":12},"Adverse effects","Adverse effects given as rate of events",{"measure":70,"description":71,"timeFrame":12},"Serum albumin value","Serum albumin absolute value",{"measure":73,"description":74,"timeFrame":33},"Change in serum albumin value","Serum albumin value compared to baseline",{"measure":76,"description":77,"timeFrame":33},"Proportion of current smokers","Current smoking at each visit",{"measure":79,"description":80,"timeFrame":33},"Quality of life questionnaire on mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression","Quality of life assessed by the EQ-5D-5L questionnaire",{"measure":82,"description":83,"timeFrame":33},"Muscle strength","Muscle strength using a handgrip dynamometer",{"measure":85,"description":86,"timeFrame":33},"Vitamin A value","Vitamin A absolute value",{"measure":88,"description":89,"timeFrame":33},"Change in vitamin A value","Change in vitamin A value compared to baseline",{"measure":91,"description":92,"timeFrame":33},"Vitamin D value","Vitamin D absolute value",{"measure":94,"description":95,"timeFrame":33},"Change in vitamin D value","Change in vitamin D value compared to baseline",{"measure":97,"description":98,"timeFrame":33},"Vitamin E value","Vitamin E absolute value",{"measure":100,"description":101,"timeFrame":33},"Change in vitamin E value","Change in vitamin E value compared to baseline",{"measure":103,"description":104,"timeFrame":33},"Vitamin K value","Vitamin K absolute value",{"measure":106,"description":107,"timeFrame":33},"Change in vitamin K value","Change in vitamin K value compared to baseline",{"measure":109,"description":110,"timeFrame":33},"Change in smoking","Change in smoking compared to baseline",{"measure":112,"description":113,"timeFrame":33},"Change in quality of life","Change in quality of life assessed by the EQ-5D-5L questionnaire compared to baseline",{"measure":115,"description":116,"timeFrame":33},"Change in muscle strength","Change in muscle strength using a handgrip dynamometer compared to baseline",null,{"allocation":119,"interventionModel":120,"interventionModelDescription":117,"primaryPurpose":121,"observationalModel":117,"timePerspective":117,"maskingInfo":122},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":123,"maskingDescription":124,"whoMasked":125},"DOUBLE","Doctors caring for the participants and assessors of all other outcomes (laboratory parameters, BMI, blood pressure, adverse events) as well as statisticians handling the data will be blinded to the participants' allocated group. Outcome assessors will be not avare of the allocated interventions.",[126,127],"CARE_PROVIDER","OUTCOMES_ASSESSOR","Around 20% of patients with acute pancreatitis (AP) will go on to have acute recurrent pancreatitis (ARP) and 10% progress to chronic pancreatitis (CP). While interventions to avoid recurrences exist for the two most common causes - removal of the cholecyst in the case of biliary, and alcohol seccation in the case of alcoholic - a method to prevent idiopathic pancreatitis is not yet known. Although none of the guidelines suggest the administration of low fat diet, it is recommended by physicians to all pancreatitis patients are. Our aim is to conduct a randomized controlled trial, to assess the problem of dietary fat reduction on the recurrence of acute pancreatitis Patients, who had at least two acute pancreatitis episodes in the preceding 2 year will be approached to participate in the study and to either to be randomized to the 'reduced fat diet' (15% fat, 65% carbohydrate, 20% protein) or to the 'standard healthy diet' (30% fat, 50% carbohydrate, 20% protein; based on WHO recommendations) group. During the 2 year long followup, participants will receive repeated dietary intervention at 3, 6, 12, 18, 24 months, they will completer food frequency questionnaires and their data regarding mortality, BMI, cardiovascular parameters and serum lipid values will be recorded The EFFORT trial will determine the effect of modified dietary fat content on the recurrence of AP, mortality, serum lipids and weight loss in idiopathic cases.",[130,136],{"label":131,"type":132,"description":133,"interventionNames":134},"Reduced fat arm","ACTIVE_COMPARATOR","Daily calorie intake will be composed of 15% fat, 65% carbohydrates, 20% proteins",[135],"Behavioral: Dietary intervention: reduced fat diet",{"label":137,"type":132,"description":138,"interventionNames":139},"Standard healthy diet arm","Daily calorie intake will be composed of 30% fat, 50% carbohydrates and 20% proteins.",[140],"Behavioral: Dietary intervention: standard healthy diet",[142,147],{"type":143,"name":144,"description":145,"armGroupLabels":146,"otherNames":117},"BEHAVIORAL","Dietary intervention: reduced fat diet","Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 15% fat, 65% carbohydrate, 20% protein content.",[131],{"type":143,"name":148,"description":149,"armGroupLabels":150,"otherNames":117},"Dietary intervention: standard healthy diet","Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content.",[137],[152],{"name":153,"affiliation":154,"role":155},"Péter Hegyi, MD, PhD, DSc","Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary","STUDY_CHAIR",[157,161],{"name":153,"role":158,"phone":159,"phoneExt":117,"email":160},"CONTACT","+36703751031","hegyi2009@gmail.com",{"name":162,"role":158,"phone":163,"phoneExt":117,"email":164},"Félix Márk Juhász, MD","+36203733370","flixjuhsz@gmail.com",[166],{"facility":167,"status":168,"city":169,"state":117,"zip":117,"country":170,"countryCode":171,"cosmosGeoPoint":172,"geoPoint":177,"contacts":178},"Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University","RECRUITING","Budapest","Hungary","HU",{"type":173,"coordinates":174},"Point",[175,176],19.04045,47.49835,{"lat":176,"lon":175},[179],{"name":180,"role":158,"phone":117,"phoneExt":117,"email":117},"Péter Hegyi, Prof.",{"type":182,"investigatorFullName":183,"investigatorTitle":184,"investigatorAffiliation":5,"oldNameTitle":117,"oldOrganization":117},"PRINCIPAL_INVESTIGATOR","Dr Hegyi Péter","Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs","100420958",false,"NCT04761523","The Effect of Dietary Fat Content on the Recurrence of Pancreatitis","The Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT): Protocol of a Multicentre Randomized Controlled Trial","EFFORT","Inclusion Criteria:\n\n* Individuals with at least two episodes of acute pancreatitis in the 2 years preceding the inclusion with\n* The last episode being idiopathic, who are\n* Older than 14 years.\n\nExclusion Criteria:\n\n* Individuals already receiving regular nutritional guidance (with medical indication),\n* Individuals in critical condition or in terminal stage of cancer (with an expected survival \\\u003C2 years) ,\n* Individuals undergoing treatment for active malignancy,\n* Individuals with uncontrolled diabetes mellitus (admitted lack of compliance with antidiabetic therapy \u002F HbA1c \\>6.5% \u002F indication of uncontrolled diabetes mellitus in last 24 months' anamnesis \u002F newly discovered diabetes mellitus)\n* Individuals with known cholecystolithiasis\n* Individuals who are pregnant or nursing\n* Individuals with a BMI \\\u003C 18.5\n* Individuals who are regularly receiving systemic corticosteroids\n* Individuals consuming more alcohol than: 5 units per day or 15 units per week for men; 4 units per day or 8 units per week for women.","ALL","14 Years",{"count":195,"type":196},384,"ESTIMATED","INTERVENTIONAL",[199],"NA","This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.",[202],"Acute Pancreatitis",[204,205,206,207],"acute pancreatitis","dietary fat","low-fat diet","pancreatitis recurrence","2022-11-14",{"date":210,"type":211},"2022-11-15","ACTUAL",{"date":213,"type":211},"2022-05-01",{"date":215,"type":196},"2026-12-31",{"name":5,"class":6},1]