Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy: A Cross-sectional Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Definition of pre-diabetes
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Definition of pre-diabetes
时间窗: through study completion, an average of 4 months
fasting plasma glucose of 100-125 mg/dL
definition of overweight
时间窗: through study completion, an average of 4 months
BMI \>25 kg/m2
diabetes mellitus
时间窗: through study completion, an average of 4 months
fasting plasma glucose \>126mg/dL
HDL-cholesterol levels
时间窗: through study completion, an average of 4 months
\<40 mg/dL for males and \<50 mg/dL for females.
Diagnosis of MAFLD
时间窗: 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)
Upper limits of waist circumference
时间窗: through study completion, an average of 4 months
≥102 cm in men and 88 cm in women
Triglyceride levels
时间窗: through study completion, an average of 4 months
≥1.70 mmol/L
Blood pressure upper limit
时间窗: through study completion, an average of 4 months
≥130/85 mmHg
次要结局
未报告次要终点
研究者
Semih Sezer
Principal Investigator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital