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

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ClinicalTrials.gov Identifier: NCT05142657
Recruitment Status : Active, not recruiting
First Posted : December 2, 2021
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Ufuk Oguz Idiz, Istanbul Training and Research Hospital

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.

Condition or disease Intervention/treatment
Diet Habit Gall Stone Pancreatitis Other: diet survey

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. .

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Study Type : Observational [Patient Registry]
Actual Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Are There Dietary Factors Affecting the Development of Pancreatitis in Patients With Gallstones?
Actual Study Start Date : June 1, 2021
Actual Primary Completion Date : November 20, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Case
Patients who have gallstone pancreatitis
Other: diet survey
Dietary survey applied to all participants

Control
Patients who have only gallstone
Other: diet survey
Dietary survey applied to all participants




Primary Outcome Measures :
  1. energy, cholesterol, protein, fat [ Time Frame: 3 days ]
    Daily energy, cholesterol, protein, fat intake of the participants



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05142657


Locations
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Turkey
Istanbul Traininng and Research Hospital
Istanbul, Turkey, 34371
Sponsors and Collaborators
Istanbul Training and Research Hospital
Investigators
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Principal Investigator: Ufuk O İdiz, M.D Istanbul Training and Research Hospital
Publications:
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Responsible Party: Ufuk Oguz Idiz, Assoc. Prof. MD. PhD, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05142657    
Other Study ID Numbers: Pancreatitis diet
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ufuk Oguz Idiz, Istanbul Training and Research Hospital:
meat
egg
fat
protein
Additional relevant MeSH terms:
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Pancreatitis
Gallstones
Pancreatic Diseases
Digestive System Diseases
Cholelithiasis
Biliary Tract Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical