The Effect of Dietary Fat Content on the Recurrence of Pancreatitis

University of Pecs384 enrolled

Overview

This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

384

Conditions

Acute Pancreatitis

Interventions

Dietary intervention: reduced fat dietBEHAVIORAL

Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 15% fat, 65% carbohydrate, 20% protein content.

Dietary intervention: standard healthy dietBEHAVIORAL

Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content.

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals with at least two episodes of acute pancreatitis in the 2 years preceding the inclusion with * The last episode being idiopathic, who are * Older than 14 years. Exclusion Criteria: * Individuals already receiving regular nutritional guidance (with medical indication), * Individuals in critical condition or in terminal stage of cancer (with an expected survival \<2 years) , * Individuals undergoing treatment for active malignancy, * Individuals with uncontrolled diabetes mellitus (admitted lack of compliance with antidiabetic therapy / HbA1c \>6.5% / indication of uncontrolled diabetes mellitus in last 24 months' anamnesis / newly discovered diabetes mellitus) * Individuals with known cholecystolithiasis * Individuals who are pregnant or nursing * Individuals with a BMI \< 18.5 * Individuals who are regularly receiving systemic corticosteroids * 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.

Locations (1)

Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University

Budapest, Hungary

RECRUITING

Outcomes

Primary Outcomes

Occurrence of recurrent acute pancreatitis and/or all-cause mortality

The recurrence of acute pancreatitis (given as a rate of event) AND/OR all-cause mortality.

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Secondary Outcomes

Proportion of pancreas specific mortality

Mortality of a pancreatic cause

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Proportion of cardiosvascular cause mortality

Mortality of a cardiovascular cause.

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Proportion of newly diagnosed chronic pancreatitis patients

Newly diagnosed chronic pancreatitis.

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Changes in BMI

Changes in BMI compared to baseline both in total and percentage

Time frame: Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits

Serum total cholesterol

Serum total cholesterol absolute value

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Change in serum total cholesterol

Serum total cholesterol compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Central Contacts

Péter Hegyi, MD, PhD, DSc

CONTACT

+36703751031 hegyi2009@gmail.com

Félix Márk Juhász, MD

CONTACT

+36203733370 flixjuhsz@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Serum triglyceride absolute value

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Change in serum triglyceride

Serum triglyceride compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Serum high density liporpotein(HDL)-cholesterol

Serum high density liporpotein(HDL)-cholesterol absolute value

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Change in serum high density liporpotein(HDL)-cholesterol

Serum high density liporpotein(HDL)-cholesterol compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Serum low density liporpotein(LDL)-cholesterol

Serum low density liporpotein(LDL)-cholesterol absolute value

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Change in serum low density liporpotein(LDL)-cholesterol

Serum low density liporpotein(LDL)-cholesterol compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Systolic blood pressure value

Systolic blood pressure absolute value

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Change in systolic blood pressure

Systolic blood pressure compared to baseline

Time frame: Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits

Diastolic blood pressure

Diastolic blood pressure absolute value

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Change in siastolic blood pressure

Diastolic blood pressure compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Adherence to dietary recommendations as determined by the result of the food frequency questionnaire

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Adverse effects

Adverse effects given as rate of events

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Serum albumin value

Serum albumin absolute value

Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits

Change in serum albumin value

Serum albumin value compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Proportion of current smokers

Current smoking at each visit

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Quality of life questionnaire on mobility, self-care, usual activities, pain/discomfort and anxiety/depression

Quality of life assessed by the EQ-5D-5L questionnaire

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Muscle strength

Muscle strength using a handgrip dynamometer

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Vitamin A value

Vitamin A absolute value

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Change in vitamin A value

Change in vitamin A value compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Vitamin D value

Vitamin D absolute value

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Change in vitamin D value

Change in vitamin D value compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Vitamin E value

Vitamin E absolute value

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Change in vitamin E value

Change in vitamin E value compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Vitamin K value

Vitamin K absolute value

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Change in vitamin K value

Change in vitamin K value compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Change in smoking

Change in smoking compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Change in quality of life

Change in quality of life assessed by the EQ-5D-5L questionnaire compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Change in muscle strength

Change in muscle strength using a handgrip dynamometer compared to baseline

Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits