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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01110577
First received: April 22, 2010
Last updated: August 12, 2010
Last verified: August 2010
History of Changes

April 22, 2010
August 12, 2010
May 2010
July 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01110577 on ClinicalTrials.gov Archive Site
ICC for repeated HFF measurements from the 3-point Dixon method [ Time Frame: 28 +/- 7 days from Imaging Visit 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)(COMPLETED)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Patients will be recruited for the study
Non-alcoholic Fatty Liver Disease (NAFLD)
Not Provided
Traveling cohort
Overweight patients with or without type 2 diabetes or pre-diabetes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01110577
2010_023, 171
No
Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP