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

NCT ID: NCT06443723

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-04-30

Brief Summary

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.

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).

Conditions

Liver Steatoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

cholecystectomy

Evaluation of hepatosteatosis by hepatobiliary ultrasonography in cholecystectomy patients. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters.

Group Type: EXPERIMENTAL

USG, blood tests, waist, hip, height and blood pressure measurements

Intervention Type: DIAGNOSTIC_TEST

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.

Control

Evaluation of hepatosteatosis by hepatobiliary ultrasonography in participants without cholecystectomy. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters.

Group Type: EXPERIMENTAL

USG, blood tests, waist, hip, height and blood pressure measurements

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Semih Sezer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CholecystectomyMAFLD

Identifier Type: -

Identifier Source: org_study_id