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

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ClinicalTrials.gov Identifier: NCT02784925
Recruitment Status : Completed
First Posted : May 27, 2016
Results First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
Taipei Medical University
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Fatty Liver Device: Ultrasound (US) B mode image Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluate Patients With Chronic Hepatitis Before and After Treatment of Body Index by Three-dimensional Force-controlled Ultrasound Measurement of Subcutaneous Fat
Study Start Date : June 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis

Arms and Interventions
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Arm Intervention/treatment
fatty liver subjects
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Subcutaneous Fat in Steatosis Patients [ Time Frame: up to 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT02784925    
Other Study ID Numbers: N201603045
First Posted: May 27, 2016    Key Record Dates
Results First Posted: June 22, 2017
Last Update Posted: June 22, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases