Clinical Trials Directory

Trials / Completed

CompletedNCT06443723

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
149 (actual)
Sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTUSG, blood tests, waist, hip, height and blood pressure measurementsMAFLD 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.

Timeline

Start date
2023-11-01
Primary completion
2024-04-30
Completion
2024-04-30
First posted
2024-06-05
Last updated
2024-06-05

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06443723. Inclusion in this directory is not an endorsement.