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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)

Study type: Observational

Funder types: Industry

Identifiers

NCT01110577

171

0000-171

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Traveling cohort

Description:

Overweight patients with or without type 2 diabetes or pre-diabetes