Non-Invasive Tests for Fatty Liver Disease

(NIMBLE Trial)

Recruiting at 3 trial locations

Overseen By Clay Dehn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Foundation for the National Institutes of Health

Must be taking: Antidiabetics, Antihypertensives

Must not be taking: Anticoagulants, Alcohol

Disqualifiers: Chronic liver disease, Alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop and confirm new, non-invasive tests for diagnosing and assessing the severity of metabolic liver disease, specifically focusing on a condition called MASH. MASH involves inflammation and fat buildup in the liver, which can lead to serious health issues. The trial seeks participants with signs of metabolic problems, such as Type 2 diabetes, high blood pressure, or high cholesterol, who are willing to undergo imaging and blood tests.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to better diagnostic tools for metabolic liver disease.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on evaluating non-invasive tests for metabolic liver disease, which could revolutionize how we diagnose and monitor this condition. Unlike traditional methods that often require invasive liver biopsies, these non-invasive tests aim to assess liver health without the discomfort and risks associated with surgery. This approach could lead to earlier detection, more frequent monitoring, and improved patient comfort and safety. If successful, these tests could make managing metabolic liver disease easier and more accessible for patients worldwide.

Who Is on the Research Team?

Arun Sanyal

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

Inclusion Criteria

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

I have signed and dated the consent form.

I have had type 2 diabetes for over 3 months with an HbA1c over 6.5.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Evaluation

Evaluation of candidate blood-based and imaging biomarkers that met prespecified criteria

Multi-year

Stage 2 Evaluation

Confirm and extend findings from Stage 1 in a prospective non-interventional trial setting

120 days

Multiple visits for biomarker evaluation

Follow-up

Participants are monitored for safety and effectiveness after biomarker evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

Foundation for the National Institutes of Health

Lead Sponsor

Trials

16

Recruited

5,800+