Foundation for the National Institutes of Health
The Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) study is a comprehensive, multi-year collaborative effort to standardize, validate and advance the regulatory qualification of blood- and imaging-based biomarkers to diagnose and stage Metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). MASH is characterized by liver inflammation accompanied by simultaneous fat accumulation in the liver.
Metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as nonalcoholic fatty liver disease (NAFLD), is a common liver problem which affects 30% of the United States population. Liver biopsy-based histopathology is accepted as the most accurate technique to detect patients at risk of developing serious liver conditions secondary to non-alcoholic steatohepatitis (MASH). However, the liver biopsy is an invasive test with risk for complications and even risk of mortality. Alternative non-invasive blood-based and imaging biomarkers are needed to replace liver biopsy for…
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged \> 18 years and \< 75 years 4. Participants must exhibit some manifestations of metabolic dysregulation. Either: A. Physician-diagnosed T2DM for at least 90 days with HbA1c \> 6.5 and antidiabetic therapy, if any, stable for at least 90 days prior to screening or B. At least any one of the following six metabolic syndrome criteria \[6\] 1\. body mass index (BMI) of \> 25 kg/m2 2. waist circ…