CompletedNCT01110577Updated Apr 9, 2015

Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)

An observational study in Non-alcoholic Fatty Liver Disease (NAFLD), sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-09.

Sponsored by Merck Sharp & Dohme LLC · Observational

Study type: Observational
Model: Cohort
Time perspective: Cross-sectional
Enrollment: 10
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Non-alcoholic Fatty Liver Disease (NAFLD)

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Keywords

MRI
Hepatic Steatosis Study

In context

Liver Diseases

2,080 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.

This study's enrollment of 10 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

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Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,111 studies on the registry; 130 are open to participants now.

Of its 488 completed or terminated interventional studies of FDA-regulated products, 361 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients will be recruited for the study

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Enrollment: 10 participants (actual)
Patient registry: No

Groups and cohorts

Traveling cohort
Overweight patients with or without type 2 diabetes or pre-diabetes

What researchers measure

Primary outcomes

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

Secondary outcomes

ICC for repeated HFF measurements from the 3-point Dixon method
Time frame: 28 +/- 7 days from Imaging Visit 1

Study locations

No study locations are listed for this record.

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01110577
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Apr 26, 2010
Start date: May 2010
Primary completion: Jul 2010
Completion: Jul 2010
Last update: Apr 9, 2015

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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