Liver Diseases Clinical Trial
— NAFLDOfficial title:
MRS Validation Study of Hepatic Triglyceride Content in Non-alcoholic Fatty Liver Disease (NAFLD)Subjects Pre- and Post-Prandial
NCT number | NCT00940537 |
Other study ID # | 06-0229 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2009 |
Est. completion date | March 2010 |
Verified date | June 2018 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 14 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Obese Exclusion Criteria: - Diabetes - Pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Barnes Jewish Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The Hepatic Triglyceride Content Pre- and 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. | after a 12 hour fast and 2 hours post-prandial | |
Secondary | T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water | T2 (spin-spin relaxation time) ratios of triglyceride/water using optimized PRESS sequences | baseline cross-sectional measurements |
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