Association Between Fatty Liver and Pancreatic Steatosis in Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Prevalence Non-Alcoholic Fatty Pancreas Disease
研究概览
简要总结
The goal of this observational study is to determine the prevalence of pancreatic steatosis in patients with fatty liver and determine the prevalence of exocrine pancreatic insufficiency (EPI) in these patients.
Participants with fatty liver and metabolic syndrome will undergo fecal elastase measurement and endoscopic ultrasound (EUS).
详细描述
The purpose of this study is to evaluate the association between non-alcoholic fatty liver disease and non-alcoholic pancreatic steatosis and to describe cytokine levels in the context of a global epidemic of obesity and metabolic syndrome, which could represent a new treatment target in previously underdiagnosed patients with pancreatic insufficiency and pancreatic steatosis.
Patients over 18 years old with a diagnosis of MAFLD (Metabolic Dysfunction-Associated Fatty Liver Disease) will undergo the following assessments:
- Exocrine Pancreatic Insufficiency Questionnaire (PEI-Q)
- Measurement of weight, height, and abdominal circumference
- Fecal elastase (Fel-1)
- Pro-inflammatory and anti-inflammatory cytokines in serum
- Hydrogen and methane breath tests to evaluate small intestinal bacterial overgrowth (SIBO)
- Endoscopic ultrasound with sedation
- Fibroscan Exocrine pancreatic insufficiency (EPI) will be defined as a fecal elastase-1 (Fel-1) concentration of < 100 µg/g or Fel-1 between 100 and 200 µg/g with alterations in additional pancreatic pathology tests, such as serum albumin, vitamin E, vitamin D, vitamin A, folic acid, iron, transferrin, calcium, magnesium, and/or malnutrition identified through anthropometric measurements conducted by an expert nutritionist. Fel-1 ≥ 200 µg/g will be considered normal.
Additionally, for those patients with fecal elastase levels below 200 µg/g, the following measurements will be conducted:
- Proteinogram
- Vitamin E, vitamin D, vitamin A, vitamin K
- Folic acid, B12
- Calcium, magnesium, zinc
- Iron profile
- Nutritional assessment with anthropometry
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old with a diagnosis of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).
排除标准
- •- Alcohol consumption >20 g/day in women, >30 g/day in men
- •Chronic hepatitis B or C infection
- •Autoimmune liver diseases: autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis
- •Hereditary hemochromatosis
- •Wilson's disease
- •Alpha-1 antitrypsin deficiency
- •Celiac disease
- •Uncontrolled thyroid disease
- •Active or chronic infectious disease
- •Active cancer or ongoing treatment
- •Chronic renal insufficiency
- •Pregnancy/lactation
- •Insufficient data
- •Patients who do not complete follow-up
结局指标
主要结局
Prevalence Non-Alcoholic Fatty Pancreas Disease
时间窗: At baseline
Determine the prevalence of Non-Alcoholic Fatty Pancreas Disease (NAFPD) in patients with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).
Prevalence of exocrine pancreatic insufficiency
时间窗: At baseline
Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Non-Alcoholic Fatty Pancreas Disease (NAFPD).
Prevalence of IPE in MAFLD
时间窗: At baseline
Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).
次要结局
- Clinical characteristics(At baseline)
- Cytokine profile(At baseline)
研究者
Maria Marta Piskorz
Principal Investigator
Hospital de Clinicas José de San Martín