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OpenTrials
Completed

NCT Number: NCT02784925

Evaluate Patients With Chronic Hepatitis by Three-dimensional Force-controlled Ultrasound Measurement

Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness. However, pressing the transducer onto the skin with too much force will significantly reduce the subcutaneous adipose tissue thickness. In this study, a force controlled system combined with US transducer was used for 3D subcutaneous fat imaging and reconstruction.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The diagnosis of fatty liver (steatosis) is made when fat in the liver exceeds 5-10% by weight. Fatty liver (FL) is commonly associated with alcohol or metabolic syndrome (diabetes, hypertension, obesity, and dyslipidemia), but can also be due to any one of many causes. Most people were detected from serum lipid abnormalities in the physical examination, and confirmed as the fatty liver disease by ultrasound imaging. In some previous studies, ultrasound was reported to provide an accurate and reliable measurement tool for the thickness measurements of subcutaneous adipose tissue. This method can overcome some limitations of the skinfold thickness measurements. Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness. However, pressing the transducer onto the skin with too much force will significantly reduce the subcutaneous adipose tissue thickness. In this study, a force controlled system combined with US transducer was used for 3D subcutaneous fat imaging and reconstruction. Finally, the correlations between body fat percentage and subcutaneous fat in steatosis patients have been investigated. The body fat percentage was determined by dual energy X-ray absorptiometry (DEXA, GE Lunar iDXA canner) and bioelectrical impedance analysis (BIA, Omron,HBF-370), and then, the correlation between body fat percentage and subcutaneous adipose tissue in normal and steatosis patients have been evaluated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged between 20-65 adults who are confirmed have fatty liver by echo

Exclusion criteria

  • none

Treatment and study plan

Ultrasound (US) B mode image

Device

Ultrasound (US) B mode image is an alternative method to measure tissue structure

and has proven to be an accurate technique to measure subcutaneous fat thickness.

Primary outcomes

  1. Subcutaneous Fat in Steatosis Patients

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Collaborators

  • Taipei Medical University

Registry information

Official study title

Evaluate Patients With Chronic Hepatitis Before and After Treatment of Body Index by Three-dimensional Force-controlled Ultrasound Measurement of Subcutaneous Fat

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 27, 2016
Registry last updated
Jun 22, 2017

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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