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

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: Liver Steatoses
• Intervention / Treatment: Diagnostic test: USG, blood tests, waist, hip, height and blood pressure measurements

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

Study Locations

• Turkey
  • Ankara, Turkey
    • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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); waist circumference ≥ 90 cm in men and 88 cm in women,; blood pressure ≥ 130/85 mmHg or on specific drug treatment,; plasma triglycerides (TG) ≥ 150 mg/dl or on specific drug treatment,; plasma high-density lipoprotein cholesterol (HDL-C) < 40 mg/dl for men and 50 mg/dl for women or on specific drug treatment,; prediabetes (FBS 100 to 125 mg/dl or HbA1c 5.7 to 6.4%),; 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); waist circumference ≥ 90 cm in men and 88 cm in women,; blood pressure ≥ 130/85 mmHg or on specific drug treatment,; plasma triglycerides (TG) ≥ 150 mg/dl or on specific drug treatment,; plasma high-density lipoprotein cholesterol (HDL-C) < 40 mg/dl for men and 50 mg/dl for women or on specific drug treatment,; prediabetes (FBS 100 to 125 mg/dl or HbA1c 5.7 to 6.4%),; 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	fasting plasma glucose >126mg/dL	through study completion, an average of 4 months
definition of overweight	BMI >25 kg/m2	through study completion, an average of 4 months
Upper limits of waist circumference	≥102 cm in men and 88 cm in women	through study completion, an average of 4 months
Definition of pre-diabetes	fasting plasma glucose of 100-125 mg/dL	through study completion, an average of 4 months
Blood pressure upper limit	≥130/85 mmHg	through study completion, an average of 4 months
HDL-cholesterol levels	<40 mg/dL for males and <50 mg/dL for females.	through study completion, an average of 4 months
Triglyceride levels	≥1.70 mmol/L	through study completion, an average of 4 months
Diagnosis of MAFLD	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

• Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Study record dates

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: obesity; cholecystectomy; Ultrasaund
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• 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