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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
  Purpose

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
Non-alcoholic Fatty Liver Disease (NAFLD)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Traveling cohort
Overweight patients with or without type 2 diabetes or pre-diabetes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited for the study

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110577

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01110577     History of Changes
Other Study ID Numbers: 2010_023, 171
Study First Received: April 22, 2010
Last Updated: August 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Merck:
MRI
Hepatic Steatosis Study

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Prediabetic State
Digestive System Diseases
 Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013