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

Liver Steatoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06443723
• Other study ID #: CholecystectomyMAFLD
• Status: Completed
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Liver Steatoses

Intervention

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.

Locations

Country	Name	City	State
Turkey	Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diabetes mellitus	fasting plasma glucose >126mg/dL	through study completion, an average of 4 months
Primary	definition of overweight	BMI >25 kg/m2	through study completion, an average of 4 months
Primary	Upper limits of waist circumference	=102 cm in men and 88 cm in women	through study completion, an average of 4 months
Primary	Definition of pre-diabetes	fasting plasma glucose of 100-125 mg/dL	through study completion, an average of 4 months
Primary	Blood pressure upper limit	=130/85 mmHg	through study completion, an average of 4 months
Primary	HDL-cholesterol levels	<40 mg/dL for males and <50 mg/dL for females.	through study completion, an average of 4 months
Primary	Triglyceride levels	=1.70 mmol/L	through study completion, an average of 4 months
Primary	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