Magnetic Resonance Spectroscopy (MRS) Validation Study in Individuals With Nonalcoholic Fatty Liver Disease (NAFLD)

NCT ID: NCT00940537

Last Updated: 2018-06-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to see how effective the investigators' optimized magnetic resonance spectroscopy (MRS) sequence in quantifying hepatic triglyceride content (HTGC) to enhance MRS as a diagnostic tool in non-alcohol fatty liver disease (NAFLD).

Detailed Description

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One way to gauge MRS as an effective diagnostic tool is by looking at the reproducibility of the liver fat measurements on subjects by calculating the coefficient of variation (CV). This study assesses the modified MRS sequence, using both breath holds and free breathing. The HTGC levels are measured twice in the same individuals on two independent events separated by 10 minutes. Subjects are then given a high fat, high carbohydrate meal of Pizza Hut pizza, Pepsi, and Oreo cookies. Two hours after eating the meal, the subjects return to the scanner and repeat all MRS scans.

Conditions

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Liver Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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NAFLD

Non-diabetic, obese with diagnosed NAFLD (HTGC greater or equal to 5.5%)

No interventions assigned to this group

Non-NAFLD

Non-diabetic, obese with no previous diagnosis of NAFLD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Obese

Exclusion Criteria

* Diabetes
* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Klein, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washinton University in St. Louis

Locations

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Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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06-0229

Identifier Type: -

Identifier Source: org_study_id

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