Metabolomic Profiling of Extracellular Vesicles in Metabolic dysfunction Associated Steatotic Liver Disease (MASLD)Spectrum
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Role of extracellular vesicles in MASLD through comparative metabolomic profiling
研究概览
简要总结
This study is a diagnostic observational case-cohort study investigating the role of extracellular vesicles in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) through metabolomic profiling and the identification of differentially expressed metabolites. It will include patients aged 18 years or older with hepatic steatosis diagnosed via imaging, biochemical tests, clinical evidence, or biopsy, along with at least one cardiometabolic criterion. The primary outcome measure will be the characterization of extracellular vesicle-associated metabolites and their potential role in MASLD pathophysiology. Secondary outcomes will include the identification of key differentially expressed metabolites and their correlation with disease severity and progression.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •For CASE group,the inclusion criteria is as follows (1)The presence of hepatic steatosis identified by imaging techniques or biochemical tests (Liver function tests) or clinical evidence or both, or by biopsy alone, with the presence of at least one of the five cardiometabolic criteria with no other identifiable causes (According to the guidelines of AASLD, 2023).
- •Cardiometabolic criteria include the following: Body Mass Index greater than or equal to 25 kilograms per square meter (23 for Asia) or Waist Circumference greater than 94 centimeters for males and greater than 80 centimeters for females or ethnicity adjusted.
- •Fasting serum glucose greater than or equal to 5.6 millimoles per liter (100 milligrams per deciliter) or two-hour post-load glucose levels greater than or equal to 7.8 millimoles per liter (greater than or equal to 140 milligrams per deciliter) or Hemoglobin A1c greater than or equal to 5.7 percent (39 millimoles per mole) or type 2 diabetes or treatment for type 2 diabetes.
- •Blood pressure greater than or equal to 130 over 85 millimeters of mercury or specific antihypertensive drug treatment.
- •Plasma triglycerides greater than or equal to 1.70 millimoles per liter (150 milligrams per deciliter) or lipid-lowering treatment.
- •Plasma High-Density Lipoprotein cholesterol less than or equal to 1.0 millimole per liter (40 milligrams per deciliter) for males and less than or equal to 1.3 millimoles per liter (50 milligrams per deciliter) for females or lipid-lowering treatment.
- •(2)Patients must be aged 18 years or older at the time of consent.
- •For CONTROL group,the inclusion criteria is as follows (1)Individuals without hepatic steatosis identified either by biochemical tests or clinical evidences, imaging techniques, or by biopsy alone with absence of cardiometabolic criteria with no other identifiable causes (2)Age 18 years or older at the time of consent.
排除标准
- •For the CASE group the exclusion criteria are as follows (1)Absence of clearly observable cardiometabolic risk factors (2)History of excess alcohol consumption (3)Diagnosis of drug-induced liver injury (4)Patients less than 18 years old at the time of consent (5)Pregnant and lactating women For the CONTROL group the exclusion criteria are as follows (1)History of liver disease, including NAFLD or MASLD.
- •(2)History of excessive alcohol consumption (3)Presence of drug-induced liver injury.
- •(4)Age less than 18 years at the time of consent.
- •(5)Pregnant or lactating women.
结局指标
主要结局
Role of extracellular vesicles in MASLD through comparative metabolomic profiling
时间窗: The primary outcome will be measured every 4 weeks for available samples till the completion of the study.
次要结局
- Differentially expressed metabolites in MASLD(The secondary outcome will be measured every six cycles of the primary outcome for the available samples until the completion of the study.)
研究者
Swasthika
Kasturba Medical College(KMC), Manipal Manipal Academy of Higher Education