Non-alcoholic Fatty Liver Disease (NAFLD)NCT01110577
Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)
An observational study of Non-alcoholic Fatty Liver Disease (NAFLD), run by Merck Sharp & Dohme LLC.
Trial summary
This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two MRI-based methods. The intra-class correlation coefficient (ICC) for the repeated measurements is expected to be greater than 0.6. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD)
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited for the study
Who may be able to join
- Patient is able to travel to MRI centers
- All patients have a BMI ≥27 kg/m2 at the prestudy (screening) visit
- Patient is male or female and at least 18 years of age
- At least 5 patients have type 2 diabetes mellitus or pre-diabetes
Who cannot join
- Female patient is pregnant or has a positive pregnancy test at screening;
- Patient has known liver disease other than fatty liver
- Patient has a history of neoplastic disease
- Patient is HIV positive
- Patient has known claustrophobia or other contraindication to MRI
About this study
Official title: Inter-Center Reproducibility Study of Magnetic Resonance Imaging (MRI) for Quantification of Hepatic Fat Fraction in Diabetic and Pre-Diabetic Patients
This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two MRI-based methods. The intra-class correlation coefficient (ICC) for the repeated measurements is expected to be greater than 0.6.
- Keywords
- MRI, Hepatic Steatosis Study
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
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 |
|---|---|---|
| Traveling cohort | Overweight patients with or without type 2 diabetes or pre-diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-class correlation coefficient (ICC) for repeated hepatic fat fraction (HFF) measurements from the LIPOQuant method
Measured: 28 +/- 7 days from Imaging Visit 1
Secondary outcomes (1)
ICC for repeated HFF measurements from the 3-point Dixon method
Measured: 28 +/- 7 days from Imaging Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110577
- Sponsor's protocol ID
- 0000-171
- Other IDs
- 171
- Status last verified
- Apr 2015
- First submitted
- 22 Apr 2010
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mashhood A, Railkar R, Yokoo T, Levin Y, Clark L, Fox-Bosetti S, Middleton MS, Riek J, Kauh E, Dardzinski BJ, Williams D, Sirlin C, Shire NJ. Reproducibility of hepatic fat fraction measurement by magnetic resonance imaging. J Magn Reson Imaging. 2013 Jun;37(6):1359-70. doi: 10.1002/jmri.23928. Epub 2012 Nov 21.
PubMed 23172799
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter-Center Reproducibility Study of Magnetic Resonance Imaging (MRI) for Quantification of Hepatic Fat Fraction in Diabetic and Pre-Diabetic Patients
- ClinicalTrials.gov ID
- NCT01110577
- Acronym / sponsor ID
- 0000-171
- Keywords
- MRI, Hepatic Steatosis Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two MRI-based methods. The intra-class correlation coefficient (ICC) for the repeated measurements is expected to be greater than 0.6.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traveling cohort | – | –Overweight patients with or without type 2 diabetes or pre-diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited for the study
Key inclusion criteria (4 listed)
- Patient is able to travel to MRI centers
- All patients have a BMI ≥27 kg/m2 at the prestudy (screening) visit
- Patient is male or female and at least 18 years of age
- At least 5 patients have type 2 diabetes mellitus or pre-diabetes
Key exclusion criteria (5 listed)
- Female patient is pregnant or has a positive pregnancy test at screening;
- Patient has known liver disease other than fatty liver
- Patient has a history of neoplastic disease
- Patient is HIV positive
- Patient has known claustrophobia or other contraindication to MRI
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
Intra-class correlation coefficient (ICC) for repeated hepatic fat fraction (HFF) measurements from the LIPOQuant method
Time frame: 28 +/- 7 days from Imaging Visit 1
1 secondary outcome
ICC for repeated HFF measurements from the 3-point Dixon method
Time frame: 28 +/- 7 days from Imaging Visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Results publication: PubMed 23172799Mashhood A, Railkar R, Yokoo T, Levin Y, Clark L, Fox-Bosetti S, Middleton MS, Riek J, Kauh E, Dardzinski BJ, Williams D, Sirlin C, Shire NJ. Reproducibility of hepatic fat fraction measurement by magnetic resonance imaging. J Magn Reson Imaging. 2013 Jun;37(6):1359-70. doi: 10.1002/jmri.23928. Epub 2012 Nov 21.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease (NAFLD), run by Merck Sharp & Dohme LLC.
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 4 inclusion and 5 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 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intra-class correlation coefficient (ICC) for repeated hepatic fat fraction (HFF) measurements from the LIPOQuant method (time frame: 28 +/- 7 days from Imaging Visit 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01110577, which also lists 1 linked publication.
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 9 Apr 2015.