Acute PancreatitisEFFORTNCT04761523
The Effect of Dietary Fat Content on the Recurrence of Pancreatitis
A study testing Dietary intervention: reduced fat diet and Dietary intervention: standard healthy diet in people with Acute Pancreatitis, run by University of Pecs at 1 site in Hungary.
Trial summary
This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Dietary intervention: reduced fat diet and Dietary intervention: standard healthy diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteHungary
- Study dates
- 1 May 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University
Budapest
Péter Hegyi, Prof.
About this study
Official title: The Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT): Protocol of a Multicentre Randomized Controlled Trial
This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.
Read the 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.
- Conditions
- Acute Pancreatitis
- Being tested
- Dietary intervention: reduced fat diet, Dietary intervention: standard healthy diet
- Keywords
- acute pancreatitis, dietary fat, low-fat diet, pancreatitis recurrence
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention: reduced fat dietBehavioural
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 dietBehavioural
Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content.
| Study group | Role | What they receive |
|---|---|---|
| Reduced fat arm | Active comparator | Daily calorie intake will be composed of 15% fat, 65% carbohydrates, 20% proteins Receives: Behavioral: Dietary intervention: reduced fat diet |
| Standard healthy diet arm | Active comparator | Daily calorie intake will be composed of 30% fat, 50% carbohydrates and 20% proteins. Receives: Behavioral: Dietary intervention: standard healthy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary outcomes (34)
Proportion of pancreas specific mortality
Mortality of a pancreatic cause
Measured: Data will be recorded during the 3-6-12-18-24 months followup visits
Proportion of cardiosvascular cause mortality
Mortality of a cardiovascular cause.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum triglyceride
Serum triglyceride absolute value
Measured: Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum triglyceride
Serum triglyceride compared to baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Adherence to dietary recommendations as determined by the result of the food frequency questionnaire
Measured: Data will be recorded during the 3-6-12-18-24 months followup visits
Adverse effects
Adverse effects given as rate of events
Measured: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum albumin value
Serum albumin absolute value
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin A value
Vitamin A absolute value
Measured: 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
Measured: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin D value
Vitamin D absolute value
Measured: 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
Measured: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin E value
Vitamin E absolute value
Measured: 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
Measured: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin K value
Vitamin K absolute value
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hegyi Péter, University of Pecs
- Investigators
- Péter Hegyi, MD, PhD, DSc, Study chair, Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761523
- Sponsor's protocol ID
- 40304-11/2020/EÜIG
- Acronym
- EFFORT
- Status last verified
- Nov 2022
- First submitted
- 15 Feb 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spanier BW, Dijkgraaf MG, Bruno MJ. Epidemiology, aetiology and outcome of acute and chronic pancreatitis: An update. Best Pract Res Clin Gastroenterol. 2008;22(1):45-63. doi: 10.1016/j.bpg.2007.10.007.
PubMed 18206812Sankaran SJ, Xiao AY, Wu LM, Windsor JA, Forsmark CE, Petrov MS. Frequency of progression from acute to chronic pancreatitis and risk factors: a meta-analysis. Gastroenterology. 2015 Nov;149(6):1490-1500.e1. doi: 10.1053/j.gastro.2015.07.066. Epub 2015 Aug 20.
PubMed 26299411Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
PubMed 24054878Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
PubMed 23896955Crockett SD, Wani S, Gardner TB, Falck-Ytter Y, Barkun AN; American Gastroenterological Association Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on Initial Management of Acute Pancreatitis. Gastroenterology. 2018 Mar;154(4):1096-1101. doi: 10.1053/j.gastro.2018.01.032. Epub 2018 Feb 3. No abstract available.
PubMed 29409760Prizment AE, Jensen EH, Hopper AM, Virnig BA, Anderson KE. Risk factors for pancreatitis in older women: the Iowa Women's Health Study. Ann Epidemiol. 2015 Jul;25(7):544-8. doi: 10.1016/j.annepidem.2014.12.010. Epub 2015 Jan 7.
PubMed 25656921Setiawan 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.
PubMed 27609706Oskarsson V, Sadr-Azodi O, Discacciati A, Orsini N, Wolk A. Overall diet quality and risk of recurrence and progression of non-gallstone-related acute pancreatitis: a prospective cohort study. Eur J Nutr. 2018 Oct;57(7):2537-2545. doi: 10.1007/s00394-017-1526-8. Epub 2017 Aug 30.
PubMed 28856418Cuevas A, Miquel JF, Reyes MS, Zanlungo S, Nervi F. Diet as a risk factor for cholesterol gallstone disease. J Am Coll Nutr. 2004 Jun;23(3):187-96. doi: 10.1080/07315724.2004.10719360.
PubMed 15190042Thomas T, Mah L, Barreto SG. Systematic review of diet in the pathogenesis of acute pancreatitis: a tale of too much or too little? Saudi J Gastroenterol. 2012 Sep-Oct;18(5):310-5. doi: 10.4103/1319-3767.101124.
PubMed 23006458Lindkvist B, Appelros S, Regner S, Manjer J. A prospective cohort study on risk of acute pancreatitis related to serum triglycerides, cholesterol and fasting glucose. Pancreatology. 2012 Jul-Aug;12(4):317-24. doi: 10.1016/j.pan.2012.05.002. Epub 2012 May 10.
PubMed 22898632Cappell MS. Acute pancreatitis: etiology, clinical presentation, diagnosis, and therapy. Med Clin North Am. 2008 Jul;92(4):889-923, ix-x. doi: 10.1016/j.mcna.2008.04.013.
PubMed 18570947Biczo G, Vegh ET, Shalbueva N, Mareninova OA, Elperin J, Lotshaw E, Gretler S, Lugea A, Malla SR, Dawson D, Ruchala P, Whitelegge J, French SW, Wen L, Husain SZ, Gorelick FS, Hegyi P, Rakonczay Z Jr, Gukovsky I, Gukovskaya AS. Mitochondrial Dysfunction, Through Impaired Autophagy, Leads to Endoplasmic Reticulum Stress, Deregulated Lipid Metabolism, and Pancreatitis in Animal Models. Gastroenterology. 2018 Feb;154(3):689-703. doi: 10.1053/j.gastro.2017.10.012. Epub 2017 Oct 23.
PubMed 29074451Zhang X, Cui Y, Fang L, Li F. Chronic high-fat diets induce oxide injuries and fibrogenesis of pancreatic cells in rats. Pancreas. 2008 Oct;37(3):e31-8. doi: 10.1097/MPA.0b013e3181744b50.
PubMed 18815536Czako L, Szabolcs A, Vajda A, Csati S, Venglovecz V, Rakonczay Z Jr, Hegyi P, Tiszlavicz L, Csont T, Posa A, Berko A, Varga C, Varga Ilona S, Boros I, Lonovics J. Hyperlipidemia induced by a cholesterol-rich diet aggravates necrotizing pancreatitis in rats. Eur J Pharmacol. 2007 Oct 15;572(1):74-81. doi: 10.1016/j.ejphar.2007.05.064. Epub 2007 Jun 13.
PubMed 17628538
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT): Protocol of a Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04761523
- Acronym / sponsor ID
- EFFORT / 40304-11/2020/EÜIG
- Conditions
- Acute Pancreatitis
- Keywords
- acute pancreatitis, dietary fat, low-fat diet, pancreatitis recurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced fat arm | Active comparator | Behavioral: Dietary intervention: reduced fat dietDaily calorie intake will be composed of 15% fat, 65% carbohydrates, 20% proteins |
| Standard healthy diet arm | Active comparator | Behavioral: Dietary intervention: standard healthy dietDaily calorie intake will be composed of 30% fat, 50% carbohydrates and 20% proteins. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention: reduced fat dietParticipants will receive a dietary intervention, and will be proposed to adhere to a diet with a 15% fat, 65% carbohydrate, 20% protein content. | Behavioural | Reduced fat arm |
| Dietary intervention: standard healthy dietParticipants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content. | Behavioural | Standard healthy diet arm |
Primary outcome
Occurrence of recurrent acute pancreatitis and/or all-cause mortality
Time frame: 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.
34 secondary outcomes
Proportion of pancreas specific mortality
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Proportion of cardiosvascular cause mortality
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Proportion of newly diagnosed chronic pancreatitis patients
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Changes in BMI
Time frame: Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Serum total cholesterol
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum total cholesterol
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum triglyceride
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum triglyceride
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
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum high density liporpotein(HDL)-cholesterol
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
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum low density liporpotein(LDL)-cholesterol
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Systolic blood pressure value
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Change in systolic blood pressure
Time frame: Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Diastolic blood pressure
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Change in siastolic blood pressure
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
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum albumin value
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum albumin value
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Proportion of current smokers
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
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Muscle strength
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin A 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
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin D 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
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin E 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
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin K 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
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in smoking
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in quality of life
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in muscle strength
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Background: PubMed 18206812Spanier BW, Dijkgraaf MG, Bruno MJ. Epidemiology, aetiology and outcome of acute and chronic pancreatitis: An update. Best Pract Res Clin Gastroenterol. 2008;22(1):45-63. doi: 10.1016/j.bpg.2007.10.007.
- Background: PubMed 26299411Sankaran SJ, Xiao AY, Wu LM, Windsor JA, Forsmark CE, Petrov MS. Frequency of progression from acute to chronic pancreatitis and risk factors: a meta-analysis. Gastroenterology. 2015 Nov;149(6):1490-1500.e1. doi: 10.1053/j.gastro.2015.07.066. Epub 2015 Aug 20.
- Background: PubMed 24054878Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
- Background: PubMed 23896955Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
- Background: PubMed 29409760Crockett SD, Wani S, Gardner TB, Falck-Ytter Y, Barkun AN; American Gastroenterological Association Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on Initial Management of Acute Pancreatitis. Gastroenterology. 2018 Mar;154(4):1096-1101. doi: 10.1053/j.gastro.2018.01.032. Epub 2018 Feb 3. No abstract available.
- Background: PubMed 25656921Prizment AE, Jensen EH, Hopper AM, Virnig BA, Anderson KE. Risk factors for pancreatitis in older women: the Iowa Women's Health Study. Ann Epidemiol. 2015 Jul;25(7):544-8. doi: 10.1016/j.annepidem.2014.12.010. Epub 2015 Jan 7.
- Background: PubMed 27609706Setiawan 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.
- Background: PubMed 28856418Oskarsson V, Sadr-Azodi O, Discacciati A, Orsini N, Wolk A. Overall diet quality and risk of recurrence and progression of non-gallstone-related acute pancreatitis: a prospective cohort study. Eur J Nutr. 2018 Oct;57(7):2537-2545. doi: 10.1007/s00394-017-1526-8. Epub 2017 Aug 30.
- Background: PubMed 15190042Cuevas A, Miquel JF, Reyes MS, Zanlungo S, Nervi F. Diet as a risk factor for cholesterol gallstone disease. J Am Coll Nutr. 2004 Jun;23(3):187-96. doi: 10.1080/07315724.2004.10719360.
- Background: PubMed 23006458Thomas T, Mah L, Barreto SG. Systematic review of diet in the pathogenesis of acute pancreatitis: a tale of too much or too little? Saudi J Gastroenterol. 2012 Sep-Oct;18(5):310-5. doi: 10.4103/1319-3767.101124.
- Background: PubMed 22898632Lindkvist B, Appelros S, Regner S, Manjer J. A prospective cohort study on risk of acute pancreatitis related to serum triglycerides, cholesterol and fasting glucose. Pancreatology. 2012 Jul-Aug;12(4):317-24. doi: 10.1016/j.pan.2012.05.002. Epub 2012 May 10.
- Background: PubMed 18570947Cappell MS. Acute pancreatitis: etiology, clinical presentation, diagnosis, and therapy. Med Clin North Am. 2008 Jul;92(4):889-923, ix-x. doi: 10.1016/j.mcna.2008.04.013.
- W.H.O. Healthy diet 2018 \[Available from: https://www.who.int/news-room/fact-sheets/detail/healthy-diet.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Péter Hegyi, MD, PhD, DSc study chair
Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention: reduced fat diet and Dietary intervention: standard healthy diet in people with Acute Pancreatitis, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Péter Hegyi, MD, PhD, DSc (+36703751031, hegyi2009@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of recurrent acute pancreatitis and/or all-cause mortality (time frame: Data will be recorded during the 3-6-12-18-24 months followup visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04761523, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.