Acute Pancreatitis
Conditions
Keywords
acute pancreatitis, dietary fat, low-fat diet, pancreatitis recurrence
Brief summary
This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.
Detailed description
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.
Interventions
BEHAVIORALDietary 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.
BEHAVIORALDietary 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.
Sponsors
University of Pecs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of recurrent acute pancreatitis and/or all-cause mortality | Data will be recorded during the 3-6-12-18-24 months followup visits | The recurrence of acute pancreatitis (given as a rate of event) AND/OR all-cause mortality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of pancreas specific mortality | Data will be recorded during the 3-6-12-18-24 months followup visits | Mortality of a pancreatic cause |
| Proportion of cardiosvascular cause mortality | Data will be recorded during the 3-6-12-18-24 months followup visits | Mortality of a cardiovascular cause. |
| Proportion of newly diagnosed chronic pancreatitis patients | Data will be recorded during the 3-6-12-18-24 months followup visits | Newly diagnosed chronic pancreatitis. |
| Changes in BMI | Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits | Changes in BMI compared to baseline both in total and percentage |
| Serum total cholesterol | Data will be recorded during the 3-6-12-18-24 months followup visits | Serum total cholesterol absolute value |
| Change in serum total cholesterol | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Serum total cholesterol compared to baseline |
| Serum triglyceride | Data will be recorded during the 3-6-12-18-24 months followup visits | Serum triglyceride absolute value |
| Change in serum triglyceride | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Serum triglyceride compared to baseline |
| Serum high density liporpotein(HDL)-cholesterol | Data will be recorded during the 3-6-12-18-24 months followup visits | Serum high density liporpotein(HDL)-cholesterol absolute value |
| Change in serum high density liporpotein(HDL)-cholesterol | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Serum high density liporpotein(HDL)-cholesterol compared to baseline |
| Serum low density liporpotein(LDL)-cholesterol | Data will be recorded during the 3-6-12-18-24 months followup visits | Serum low density liporpotein(LDL)-cholesterol absolute value |
| Change in serum low density liporpotein(LDL)-cholesterol | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Serum low density liporpotein(LDL)-cholesterol compared to baseline |
| Systolic blood pressure value | Data will be recorded during the 3-6-12-18-24 months followup visits | Systolic blood pressure absolute value |
| Change in systolic blood pressure | Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits | Systolic blood pressure compared to baseline |
| Diastolic blood pressure | Data will be recorded during the 3-6-12-18-24 months followup visits | Diastolic blood pressure absolute value |
| Change in siastolic blood pressure | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Diastolic blood pressure compared to baseline |
| Vitamin D value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Vitamin D absolute value |
| Adverse effects | Data will be recorded during the 3-6-12-18-24 months followup visits | Adverse effects given as rate of events |
| Serum albumin value | Data will be recorded during the 3-6-12-18-24 months followup visits | Serum albumin absolute value |
| Change in serum albumin value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Serum albumin value compared to baseline |
| Proportion of current smokers | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Current smoking at each visit |
| Quality of life questionnaire on mobility, self-care, usual activities, pain/discomfort and anxiety/depression | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Quality of life assessed by the EQ-5D-5L questionnaire |
| Muscle strength | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Muscle strength using a handgrip dynamometer |
| Vitamin A value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Vitamin A absolute value |
| Change in vitamin A value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Change in vitamin A value compared to baseline |
| Change in vitamin D value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Change in vitamin D value compared to baseline |
| Vitamin E value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Vitamin E absolute value |
| Change in vitamin E value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Change in vitamin E value compared to baseline |
| Vitamin K value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Vitamin K absolute value |
| Change in vitamin K value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Change in vitamin K value compared to baseline |
| Change in smoking | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Change in smoking compared to baseline |
| Change in quality of life | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Change in quality of life assessed by the EQ-5D-5L questionnaire compared to baseline |
| Change in muscle strength | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits | Change in muscle strength using a handgrip dynamometer compared to baseline |
| Adherence to dietary recommendations as determined by the result of the food frequency questionnaire | Data will be recorded during the 3-6-12-18-24 months followup visits | Adherence to dietary recommendations as determined by the result of the food frequency questionnaire |
Countries
Hungary
Contacts
Primary ContactPéter Hegyi, MD, PhD, DSc
Backup ContactFélix Márk Juhász, MD
Outcome results
None listed