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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01110577
Recruitment Status : Completed
First Posted : April 26, 2010
Last Update Posted : April 9, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease
Non-alcoholic Fatty Liver Disease (NAFLD)

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Inter-Center Reproducibility Study of Magnetic Resonance Imaging (MRI) for Quantification of Hepatic Fat Fraction in Diabetic and Pre-Diabetic Patients
Study Start Date : May 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. ICC for repeated HFF measurements from the 3-point Dixon method [ Time Frame: 28 +/- 7 days from Imaging Visit 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01110577

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01110577     History of Changes
Other Study ID Numbers: 0000-171
First Posted: April 26, 2010    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Hepatic Steatosis Study
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Prediabetic State
Digestive System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases