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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease (NAFLD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Traveling cohort

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No