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

NCT06443723 | Completed

• 1 other identifier: CholecystectomyMAFLD
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Steatoses

Keywords

Ultrasaund; obesity; cholecystectomy

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

cholecystectomy

EXPERIMENTAL

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

Control

EXPERIMENTAL

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatty Liver; Obesity

Interventions

Hematologic Tests; Body Height; Blood Pressure

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Physical Appearance, Body; Anthropometry; Physiological Phenomena; Growth; Growth and Development; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: June 5, 2024
• Study Start: November 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-05

Locations

TU (1)