Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
MAHE-IMF
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Role of extracellular vesicles in MASLD through comparative metabolomic profilingTimepoint: The primary outcome will be measured every 4 weeks for available samples till the completion of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Differentially expressed metabolites in MASLDTimepoint: The secondary outcome will be measured every six cycles of the primary outcome for the available samples until the completion of the study. | — |
Countries
India
Contacts
Public ContactDr Athish Shetty
Department of Biochemistry, Kasturba Medical College(KMC), Manipal Manipal Academy of Higher Education,Manipal
Outcome results
None listed