Are There Dietary Factors Affecting the Development of Pancreatitis in Patients With Gallstones?
1 other identifier
observational
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2021
CompletedFirst Submitted
Initial submission to the registry
November 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 2, 2021
CompletedApril 14, 2022
November 1, 2021
6 months
November 21, 2021
April 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
energy, cholesterol, protein, fat
Daily energy, cholesterol, protein, fat intake of the participants
3 days
Study Arms (2)
Case
Patients who have gallstone pancreatitis
Control
Patients who have only gallstone
Interventions
Eligibility Criteria
All the participants have gallstone. In control group participants did not have any pancreatitis history. In case group patients have pancreatitis.
You may qualify if:
- years of age,
- having gallbladder stones
You may not qualify if:
- having any cancer,
- being pregnant,
- having chronic liver or kidney disease,
- icterus,
- developing after ERCP.
- years of age
- any cancer,
- pregnancy,
- chronic liver or kidney disease,
- icterus,
- previous pancreatitis attack
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Traininng and Research Hospital
Istanbul, 34371, Turkey (Türkiye)
Related Publications (2)
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: 27609706BACKGROUNDDugum 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.
PMID: 30569031BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ufuk O İdiz, M.D
Istanbul Training and Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 7 Days
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. MD. PhD
Study Record Dates
First Submitted
November 21, 2021
First Posted
December 2, 2021
Study Start
June 1, 2021
Primary Completion
November 20, 2021
Study Completion
December 1, 2021
Last Updated
April 14, 2022
Record last verified: 2021-11