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NCT Number: NCT06443723

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

  • 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.

Primary outcomes

  1. diabetes mellitus

    Time frame: through study completion, an average of 4 months

    fasting plasma glucose >126mg/dL

  2. definition of overweight

    Time frame: through study completion, an average of 4 months

    BMI >25 kg/m2

  3. Upper limits of waist circumference

    Time frame: through study completion, an average of 4 months

    ≥102 cm in men and 88 cm in women

  4. Definition of pre-diabetes

    Time frame: through study completion, an average of 4 months

    fasting plasma glucose of 100-125 mg/dL

  5. Blood pressure upper limit

    Time frame: through study completion, an average of 4 months

    ≥130/85 mmHg

  6. HDL-cholesterol levels

    Time frame: through study completion, an average of 4 months

    <40 mg/dL for males and <50 mg/dL for females.

  7. Triglyceride levels

    Time frame: through study completion, an average of 4 months

    ≥1.70 mmol/L

  8. Diagnosis of MAFLD

    Time frame: through study completion, an average of 4 months

    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)

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2024
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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