Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) Study 2.0 - An FNIH Biomarkers Consortium Study
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.
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged \> 18 years and \< 75 years
• 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 circumference: i. \> 102 cm for men ii. \> 88.9 cm for women 3. fasting triglyceride concentration \> 150 mg/dL i. or ongoing treatment with triglyceride lowering medication 4. HDL-cholesterol concentration: i. \< 40 mg/dL for men ii. \< 50 mg/dL for women iii. or ongoing treatment with cholesterol lowering medication. 5. fasting glucose concentration \> 100 mg/dL 6. either semi-recumbent or supine blood pressure systolic \> 130 mmHg and/ or diastolic \> 85 mmHg i. or ongoing treatment with antihypertensive medication. 5. FIB-4 \> 1.3 (age \< 65 years) and \> 2.0 (age \> 65 years) 6. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration