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OpenTrials
Completed

NCT Number: NCT01110577

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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. ICC for repeated HFF measurements from the 3-point Dixon method

    Time frame: 28 +/- 7 days from Imaging Visit 1

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Inter-Center Reproducibility Study of Magnetic Resonance Imaging (MRI) for Quantification of Hepatic Fat Fraction in Diabetic and Pre-Diabetic Patients

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 26, 2010
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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