Liver DiseasesNAFLDNCT00940537
Magnetic Resonance Spectroscopy (MRS) Validation Study in Individuals With Nonalcoholic Fatty Liver Disease (NAFLD)
An observational study of Liver Diseases, run by Washington University School of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Mar 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: St. Louis community
Who may be able to join
- Obese
Who cannot join
- Diabetes
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MRS Validation Study of Hepatic Triglyceride Content in Non-alcoholic Fatty Liver Disease (NAFLD)Subjects Pre- and Post-Prandial
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).
Read the detailed description
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.
- Conditions
- Liver Diseases
- Keywords
- Obese, MRS, hepatic triglyceride content, MR spectroscopy
- Medical subject headings
- Liver Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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
Measured: baseline cross-sectional measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, M.D., Principal investigator, Washinton University in St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940537
- Sponsor's protocol ID
- 06-0229
- Acronym
- NAFLD
- Status last verified
- Jun 2018
- First submitted
- 14 Jul 2009
- Last updated
- 15 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRS Validation Study of Hepatic Triglyceride Content in Non-alcoholic Fatty Liver Disease (NAFLD)Subjects Pre- and Post-Prandial
- ClinicalTrials.gov ID
- NCT00940537
- Acronym / sponsor ID
- NAFLD / 06-0229
- Conditions
- Liver Diseases
- Keywords
- Obese, MRS, hepatic triglyceride content, MR spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Posted 13 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- St. Louis community
Key inclusion criteria (1 listed)
- Obese
Key exclusion criteria (2 listed)
- Diabetes
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
The Hepatic Triglyceride Content Pre- and Post-prandial.
Time frame: after a 12 hour fast and 2 hours post-prandial
T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water
Time frame: baseline cross-sectional measurements
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Klein, M.D. principal investigator
Washinton University in St. Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Reproducibility of the Hepatic Triglyceride Content Measurement by MRS. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.