Are There Dietary Factors Affecting the Development of Pancreatitis in Patients With Gallstones?

April 13, 2022 updated by: Ufuk Oguz Idiz, Istanbul Training and Research Hospital
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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The incidence of acute pancreatitis has been reported as 4.9-35/100.000, and the incidence increases every year with the increase in obesity and gallstone rates. It is most commonly observed between the ages of 30-60 and no difference was found in terms of gender distribution. The most common cause of acute pancreatitis is gallstones. Alcohol use, drugs and other reasons come next.

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. In addition, many studies have reported that increased use of dietary refined carbohydrates and triglycerides and reduced dietary fiber intake are associated with gallstone formation.

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. On the other hand, Sarles et al. In a comprehensive study conducted in 1973, he reported that high fat and protein consumption and alcoholism increase the risk of pancreatitis, regardless of etiology. Few case-control and ecological studies have evaluated the effect of protein, fat, and carbohydrate intakes on alcohol-related or gallstone-related acute pancreatitis risk or non-gallstone-related acute pancreatitis risk or acute pancreatitis mortality.

At the beginning of the twentieth century, an inverse relationship between coffee consumption and the risk of alcohol-induced acute pancreatitis was observed in a prospective study, and an inverse relationship with fruit consumption in two smaller case-control studies, and a positive association with consumption of freshwater fish and parboiled rice. In parallel, overly large meals and food allergies after a long period of fasting have been reported to be risk factors for acute pancreatitis.

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.

In the study, age, gender, body mass index, alcohol and cigarette consumption status, daily physical activity status, eating frequency, frequency of food consumption for three days, and their food consumption status will be evaluated with the BeBis 8 Full version program and it will be compared whether there is a difference between patients who had pancreatitis and those who did not. .

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34371
        • Istanbul Traininng and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion criteria in the pancreatitis group were :

  • 18-80 years of age,
  • having gallbladder stones
  • being diagnosed with pancreatitis, exclusion criteria in the pancreatitis group were:
  • having any cancer,
  • being pregnant,
  • having chronic liver or kidney disease,
  • icterus,
  • developing after ERCP.

Inclusion criteria in the control group were:

  • 18-80 years of age
  • gallbladder stones, exclusion criteria in the control group were:
  • any cancer,
  • pregnancy,
  • chronic liver or kidney disease,
  • icterus,
  • previous pancreatitis attack

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case
Patients who have gallstone pancreatitis
Dietary survey applied to all participants
Control
Patients who have only gallstone
Dietary survey applied to all participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
energy, cholesterol, protein, fat
Time Frame: 3 days
Daily energy, cholesterol, protein, fat intake of the participants
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ufuk O İdiz, M.D, Istanbul Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

November 20, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

November 21, 2021

First Submitted That Met QC Criteria

November 21, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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