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

April 8, 2015 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited for the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
28 +/- 7 days from Imaging Visit 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

April 22, 2010

First Submitted That Met QC Criteria

April 23, 2010

First Posted (ESTIMATE)

April 26, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-171
  • 171

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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