An observational study in Liver Diseases, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-15.
Sponsored by Washington University School of Medicine · 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).
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 14 is below the median of 167 across 681 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
Non-diabetic, obese with diagnosed NAFLD (HTGC greater or equal to 5.5%)
Non-diabetic, obese with no previous diagnosis of NAFLD
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.
Time frame: 6 months
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.
Time frame: after a 12 hour fast and 2 hours post-prandial
T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water
T2 (spin-spin relaxation time) ratios of triglyceride/water using optimized PRESS sequences
Time frame: baseline cross-sectional measurements
Subjects were recruited through the Center for Human Nutrition (CHN) beginning in July, 2009. Many had previously been enrolled in other CHN studies. The final subject was tested in December, 2009.
| Milestone | NAFLD | Non-NAFLD |
|---|---|---|
| Started | 5 | 9 |
| Completed | 5 | 9 |
| Not completed | 0 | 0 |
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.
| coefficient of variation | NAFLD | Non-NAFLD |
|---|---|---|
| Siemens sequence | 13.0 ± 9.6 | 23.5 ± 1.1 |
| Optimized sequence | 4.4 ± 3.9 | 9.7 ± 0.1 |
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.
| ratio | NAFLD | Non-NAFLD |
|---|---|---|
| fasting | 30 ± 12 | 8 ± 7 |
| post-prandial | 27 ± 9 | 8 ± 7 |
T2 (spin-spin relaxation time) ratios of triglyceride/water using optimized PRESS sequences
| ratio | All Subjects |
|---|---|
| Low IHTG | 0.9 ± 0.1 |
| Medium IHTG | 1.1 ± 0.1 |
| High IHTG | 1.1 ± 0.1 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NAFLD | — | 0/5 (0%) | 0/5 (0%) |
| Non-NAFLD | — | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | NAFLD | Non-NAFLD | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 8 | 13 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | NAFLD | Non-NAFLD | Total |
|---|---|---|---|
| Mean | 43 ± 13 | 46 ± 12 | 45 ± 12 |
| Sex: Female, Male(Participants) | NAFLD | Non-NAFLD | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 1 | 5 | 6 |
| Region of Enrollment(participants) | NAFLD | Non-NAFLD | Total |
|---|---|---|---|
| United States | 5 | 9 | 14 |
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine