Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) Study 2.0 - An FNIH Biomarkers Consortium Study

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
View:

• 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

Locations
United States
Florida
Clinical Pharmacology of Miami
RECRUITING
Miami
Ohio
Ohio Clinical Trials
RECRUITING
Columbus
Texas
First Surgical Hospital
RECRUITING
Bellaire
Endeavor Clinical Trials
RECRUITING
San Antonio
Contact Information
Primary
Geraldine Dacpano
gdacpano@ergclinical.com
908-650-1353
Backup
Clay Dehn
cdehn@ergclinical.com
908-484-4110
Time Frame
Start Date: 2025-05-13
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 400
Sponsors
Leads: Foundation for the National Institutes of Health

This content was sourced from clinicaltrials.gov