Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy Patients

May 30, 2024 updated by: Semih Sezer, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy: A Cross-sectional Case-control Study

The aim of this study was to examine the association between metabolic associated fatty liver disease (MAFLD) in participants who had undergone cholecystectomy and those who had not undergone cholecystectomy. MAFLD is defined as hepatic steatosis(with ultrasonography) entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.

In this way, the long-term effects of cholecystectomy surgeries, which are commonly performed in the society and thought to be harmless, will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cholecystectomy is known to be a harmless operation with low perioperative mortality and morbidity. However, the unexplained increase in metabolic disorders in cholecystectomy patients has led to the need for further investigation of cholecystectomy patients. Non-alcoholic fatty liver disease is an important health problem with an average prevalence of 25% worldwide and serious hepatic and systemic complications. The aim of this study was to examine the association of cholecystectomy with metabolic dysfunction associated fatty liver disease (MAFLD), which is an important public health problem in the long-term.

This case-controlled cross-sectional study was planned to evaluate the relationship between patients who had undergone cholecystectomy with MAFLD. MAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.

The study included 86 participants with cholecystectomy and 63 participants without cholecystectomy. It was planned to compare the participants according to the diagnostic criteria for MAFLD (with or without MAFLD).

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

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

  • Turkey
      • Ankara, Turkey
        • Dr. Abdurrahman Yurtaslan Oncology Training 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • who were found to have undergone cholecystectomy at least five years ago,
  • who could feed orally and perform activities of daily living
  • participants who had not undergone cholecystectomy with similar characteristics were included in the study

Exclusion Criteria:

  • those with chronic liver disease
  • malignancy or history of malignancy
  • in a chemotherapy program
  • with active infection
  • any organ failure
  • pregnancy
  • use of drugs that cause steatosis in the liver

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cholecystectomy
Evaluation of hepatosteatosis by hepatobiliary ultrasonography in cholecystectomy patients. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters.
Diagnostic test: USG, blood tests, waist, hip, height and blood pressure measurements

MAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, DM, or evidence of metabolic dysfunction.

Metabolic dysfunction (two or more of the following)

  1. waist circumference ≥ 90 cm in men and 88 cm in women,
  2. blood pressure ≥ 130/85 mmHg or on specific drug treatment,
  3. plasma triglycerides (TG) ≥ 150 mg/dl or on specific drug treatment,
  4. plasma high-density lipoprotein cholesterol (HDL-C) < 40 mg/dl for men and 50 mg/dl for women or on specific drug treatment,
  5. prediabetes (FBS 100 to 125 mg/dl or HbA1c 5.7 to 6.4%),
  6. homeostasis model assessment of insulin resistance (HOMA-IR) score ≥ 2.5.
Experimental: Control
Evaluation of hepatosteatosis by hepatobiliary ultrasonography in participants without cholecystectomy. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters.
Diagnostic test: USG, blood tests, waist, hip, height and blood pressure measurements

MAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, DM, or evidence of metabolic dysfunction.

Metabolic dysfunction (two or more of the following)

  1. waist circumference ≥ 90 cm in men and 88 cm in women,
  2. blood pressure ≥ 130/85 mmHg or on specific drug treatment,
  3. plasma triglycerides (TG) ≥ 150 mg/dl or on specific drug treatment,
  4. plasma high-density lipoprotein cholesterol (HDL-C) < 40 mg/dl for men and 50 mg/dl for women or on specific drug treatment,
  5. prediabetes (FBS 100 to 125 mg/dl or HbA1c 5.7 to 6.4%),
  6. homeostasis model assessment of insulin resistance (HOMA-IR) score ≥ 2.5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diabetes mellitus
Time Frame: through study completion, an average of 4 months
fasting plasma glucose >126mg/dL
through study completion, an average of 4 months
definition of overweight
Time Frame: through study completion, an average of 4 months
BMI >25 kg/m2
through study completion, an average of 4 months
Upper limits of waist circumference
Time Frame: through study completion, an average of 4 months
≥102 cm in men and 88 cm in women
through study completion, an average of 4 months
Definition of pre-diabetes
Time Frame: through study completion, an average of 4 months
fasting plasma glucose of 100-125 mg/dL
through study completion, an average of 4 months
Blood pressure upper limit
Time Frame: through study completion, an average of 4 months
≥130/85 mmHg
through study completion, an average of 4 months
HDL-cholesterol levels
Time Frame: through study completion, an average of 4 months
<40 mg/dL for males and <50 mg/dL for females.
through study completion, an average of 4 months
Triglyceride levels
Time Frame: through study completion, an average of 4 months
≥1.70 mmol/L
through study completion, an average of 4 months
Diagnosis of MAFLD
Time Frame: through study completion, an average of 4 months
hepatic steatosis + (diabetes mellitus and/or overweight and/or metabolic dysfunction) metabolic dysfunction is defined as the presence of at least two criteria(Pre-diabetes, TG, HDL, blood pressure, waist circumference)
through study completion, an average of 4 months

Collaborators and Investigators

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

Sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

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)

November 1, 2023

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

May 19, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CholecystectomyMAFLD

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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