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Completed

NCT Number: NCT00940537

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

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).

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Key information

Conditions

Liver Diseases Body Weight Digestive System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obese

Exclusion criteria

  • Diabetes
  • Pregnant

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

MRS Validation Study of Hepatic Triglyceride Content in Non-alcoholic Fatty Liver Disease (NAFLD)Subjects Pre- and Post-Prandial

Acronym: NAFLD

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 16, 2009
Registry last updated
Jun 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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