NCT05142657

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 21, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
Last Updated

April 14, 2022

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

November 21, 2021

Last Update Submit

April 13, 2022

Conditions

Keywords

meateggfatprotein

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

Other: diet survey

Control

Patients who have only gallstone

Other: diet survey

Interventions

Dietary survey applied to all participants

CaseControl

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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)

Location

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: 27609706BACKGROUND
  • Dugum 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

Feeding BehaviorGallstonesPancreatitisPlatelet Glycoprotein IV Deficiency

Interventions

Diet Surveys

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorCholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPancreatic Diseases

Intervention Hierarchy (Ancestors)

Nutrition SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Ufuk O İdiz, M.D

    Istanbul Training and Research Hospital

    PRINCIPAL INVESTIGATOR

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

Locations