Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02784925
Enrollment
30
Registered
2016-05-27
Start date
2016-06-30
Completion date
2016-07-31
Last updated
2017-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver

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.

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.

Interventions

DEVICEUltrasound (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.

Sponsors

Taipei Medical University
CollaboratorOTHER
Taipei Medical University WanFang Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frame
Subcutaneous Fat in Steatosis Patientsup to 6 months

Participant flow

Participants by arm

ArmCount
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. 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.
30
Total30

Baseline characteristics

CharacteristicFatty Liver Subjects
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
30 Participants
Sex: Female, Male
Female
21 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
30 / 30
serious
Total, serious adverse events
30 / 30

Outcome results

Primary

Subcutaneous Fat in Steatosis Patients

Time frame: up to 6 months

Population: fatty liver patients

ArmMeasureGroupValue (MEAN)
Fatty Liver SubjectsSubcutaneous Fat in Steatosis Patientsfemale__abdomen9.54 cm^3
Fatty Liver SubjectsSubcutaneous Fat in Steatosis Patientsmale__abdomen10.48 cm^3
Fatty Liver SubjectsSubcutaneous Fat in Steatosis Patientsfemale__front thigh5.24 cm^3
Fatty Liver SubjectsSubcutaneous Fat in Steatosis Patientsmale__front thigh4.09 cm^3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026