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

Fatty Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784925
• Other study ID #: N201603045
• Status: Completed
• Phase: N/A
• First received: May 20, 2016
• Last updated: June 20, 2017
• Start date: June 2016
• Est. completion date: July 2016

Study information

• Verified date: April 2016
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Fatty Liver
• Hepatitis, Chronic

Intervention

Device:
• Ultrasound (US) B mode image
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital	Taipei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subcutaneous Fat in Steatosis Patients		up to 6 months