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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06443723
Enrollment
149
Registered
2024-06-05
Start date
2023-11-01
Completion date
2024-04-30
Last updated
2024-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Steatoses

Keywords

Ultrasaund, obesity, cholecystectomy

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).

Interventions

DIAGNOSTIC_TESTUSG, 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.

Sponsors

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Definition of pre-diabetesthrough study completion, an average of 4 monthsfasting plasma glucose of 100-125 mg/dL
Blood pressure upper limitthrough study completion, an average of 4 months≥130/85 mmHg
HDL-cholesterol levelsthrough study completion, an average of 4 months\<40 mg/dL for males and \<50 mg/dL for females.
Triglyceride levelsthrough study completion, an average of 4 months≥1.70 mmol/L
diabetes mellitusthrough study completion, an average of 4 monthsfasting plasma glucose \>126mg/dL
definition of overweightthrough study completion, an average of 4 monthsBMI \>25 kg/m2
Upper limits of waist circumferencethrough study completion, an average of 4 months≥102 cm in men and 88 cm in women
Diagnosis of MAFLDthrough study completion, an average of 4 monthshepatic 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)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026