Magnetic Resonance Spectroscopy (MRS) Validation Study in Individuals With Nonalcoholic Fatty Liver Disease (NAFLD)
NAFLD
MRS Validation Study of Hepatic Triglyceride Content in Non-alcoholic Fatty Liver Disease (NAFLD)Subjects Pre- and Post-Prandial
1 other identifier
observational
14
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
May 13, 2010
CompletedJune 15, 2018
June 1, 2018
9 months
July 14, 2009
April 13, 2010
June 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Reproducibility of the Hepatic Triglyceride Content Measurement by MRS.
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.
6 months
Secondary Outcomes (2)
The Hepatic Triglyceride Content Pre- and Post-prandial.
after a 12 hour fast and 2 hours post-prandial
T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water
baseline cross-sectional measurements
Study Arms (2)
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
Eligibility Criteria
St. Louis community
You may qualify if:
- Obese
You may not qualify if:
- Diabetes
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Skolnick
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Klein, M.D.
Washinton University in St. Louis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2009
First Posted
July 16, 2009
Study Start
June 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
June 15, 2018
Results First Posted
May 13, 2010
Record last verified: 2018-06