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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00940537
First Posted: July 16, 2009
Last Update Posted: July 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Washington University School of Medicine
  Purpose
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).

Condition
Liver Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: MRS Validation Study of Hepatic Triglyceride Content in Non-alcoholic Fatty Liver Disease (NAFLD)Subjects Pre- and Post-Prandial

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The Reproducibility of the Hepatic Triglyceride Content Measurement by MRS. [ Time Frame: 6 months ]
    We compared three 1H-Magnetic Resonance Spectroscopy sequences: A Standard Siemens sequence, and an optimized sequence with either breath-holds or free-breathing. Repeat scans were done with the subject briefly removed from and returned to the scanner between scans. The results given are coefficients of variation of the triglyceride signal divided by the water signal.


Secondary Outcome Measures:
  • The Hepatic Triglyceride Content Pre- and Post-prandial. [ Time Frame: after a 12 hour fast and 2 hours post-prandial ]
    We compared the intrahepatic triglyceride content in subjects after a 12 hour fast and 2 hours after eating a high fat, high carbohydrate meal. The measure reported here is for the pre and post prandial results given as the ratio of triglyceride signal to water signal. After showing its reliability, we chose to use the results from the optimized breath-hold sequence.

  • T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water [ Time Frame: baseline cross-sectional measurements ]
    T2 (spin-spin relaxation time) ratios of triglyceride/water using optimized PRESS sequences


Enrollment: 14
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
NAFLD
Non-diabetic, obese with diagnosed NAFLD (HTGC greater or equal to 5.5%)
Non-NAFLD
Non-diabetic, obese with no previous diagnosis of NAFLD

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
St. Louis community
Criteria

Inclusion Criteria:

  • Obese

Exclusion Criteria:

  • Diabetes
  • Pregnant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940537


Locations
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Samuel Klein, M.D. Washinton University in St. Louis
  More Information

Responsible Party: Samuel Klein, M.D., Washington Univeristy in St. Louis
ClinicalTrials.gov Identifier: NCT00940537     History of Changes
Other Study ID Numbers: 06-0229
First Submitted: July 14, 2009
First Posted: July 16, 2009
Results First Submitted: April 13, 2010
Results First Posted: May 13, 2010
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Washington University School of Medicine:
Obese
MRS
hepatic triglyceride content
MR spectroscopy

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases