Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)

Merck Sharp & Dohme LLC10 enrolled

Overview

This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two MRI-based methods. The intra-class correlation coefficient (ICC) for the repeated measurements is expected to be greater than 0.6.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is able to travel to MRI centers * All patients have a BMI ≥27 kg/m2 at the prestudy (screening) visit * Patient is male or female and at least 18 years of age * At least 5 patients have type 2 diabetes mellitus or pre-diabetes Exclusion Criteria: * Female patient is pregnant or has a positive pregnancy test at screening; * Patient has known liver disease other than fatty liver * Patient has a history of neoplastic disease * Patient is HIV positive * Patient has known claustrophobia or other contraindication to MRI

Outcomes

Primary Outcomes

Intra-class correlation coefficient (ICC) for repeated hepatic fat fraction (HFF) measurements from the LIPOQuant method

Time frame: 28 +/- 7 days from Imaging Visit 1

Secondary Outcomes

ICC for repeated HFF measurements from the 3-point Dixon method

Time frame: 28 +/- 7 days from Imaging Visit 1

Data from ClinicalTrials.gov

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