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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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St. Louis community
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Klein, M.D. | Washinton University in St. Louis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
All enrolled subjects completed the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | NAFLD | Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%) |
| FG001 | Non-NAFLD | Non-diabetic, obese with no previous diagnosis of NAFLD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | NAFLD | Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%) |
| BG001 | Non-NAFLD | Non-diabetic, obese with no previous diagnosis of NAFLD |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mar 2010 | Mean | Standard Error | coefficient of variation | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NAFLD | Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Skolnick | Washington University School of Medicine | 314-362-5292 | gskolnic@wustl.edu |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 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 | baseline cross-sectional measurements |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
| 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. | Posted | Mar 2010 | Mean | Standard Error | ratio | 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 | This analysis was per protocol. | Posted | Mean | Standard Deviation | ratio | baseline cross-sectional measurements |
|
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|
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| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Non-NAFLD | Non-diabetic, obese with no previous diagnosis of NAFLD | 0 | 9 | 0 | 9 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title |
|---|
| Measurements |
|---|
|
null hypothesis was that the T2 ratio would not depend on level of intra-hepatic triglyceride (IHTG) and would be equal for the low (<5%) and high (>10%) IHTG categories. |
| t-test, 2 sided |
| <0.0001 |
The a priori threshold for statistical significance was p<0.05. |
| 95 |
| Superiority or Other |
| The null hypothesis was that there would be no difference in T2 relaxation ratios for varying levels of intra-hepatic triglyceride (IHTG). Thus the medium (5 - 10%) and high (<10%) IHTG groups would not be statistically different with regard to average T2 ratio. | t-test, 2 sided | .93 | The a priori threshold for statistical significance was set at p<0.05. | 95 | Superiority or Other |