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Effect of Focused Ultrasound on Abdominal and Intrahepatic Fat in Patients With Non-alcoholic Fatty Liver Disease

Effect of Focused Ultrasound on Abdominal and Intrahepatic Fat in Patients With Non-alcoholic Fatty Liver Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04161703
Enrollment
50
Registered
2019-11-13
Start date
2019-11-20
Completion date
2020-03-20
Last updated
2020-05-04

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

Conditions

Fatty Liver

Brief summary

In recent years, a number of modalities have become available for the noninvasive reduction of adipose tissue. One of those is high intensity focused ultra sound (HIFU). The study aimed to discover the effect of Focused Ultrasound on localized abdominal fat size in fatty liver patients. Methods: In total, 40 participants with a body mass index (BMI) 30-40 kg/m2, whose age ranged between 30 and 45 years, mild to moderate fatty liver (Liver to Spleen ratio \< 1), and with waist-hip ratio (WHR) greater than 0.8 for females and greater than 0.95 for males were included. The participants were randomly assigned to two groups, one group received focused ultrasound, diet, and exercises (the study group) and the other group received exercises, and diet only (the control group), respectively. Measures were abdominal subcutaneous fat volume, abdominal visceral fat volume, and liver to spleen ratio (L/S ratio) were measured at the beginning of the study and 3 months later.

Interventions

PROCEDUREfocused ultrasound, diet and exercise

Focused Ultra Sound using a device of Mabel6 DUO Ultra Cavitation Technology produced by DAEYANG MEDICAL CO., KOREA applied on the abdominal region which extending bilaterally from the line extending from mid-axilla to iliac crest, and above from center of diaphragm to the line extending between two iliac crests below. an aerobic exercise 3 to5 times/week for 12 weeks in the form of walking on treadmill for 30 minutes with moderate intensity a weight maintenance diet, which ranged from 1700 kcal to 2200 kcal/day, which was calculated in an individual basis for each subject according to his BMR, throughout the study period (12 weeks) to ensure that the reduction in the circumference was due to the treatment intervention rather than due to their weight reduction

PROCEDUREdiet and exercise

weight maintenance diet, which ranged from 1700 kcal to 2200 kcal/day, which was calculated in an individual basis for each subject according to his BMR, throughout the study period (12 weeks) to ensure that the reduction in the circumference was due to the treatment intervention rather than due to their weight reduction. All subjects in both groups (A & B) followed an aerobic exercise 3 to5 times/week for 12 weeks in the form of walking on treadmill for 30 minutes with moderate intensity (moderate intensity = 12-14 according to Borg Scale). The beginning period will be 15 mints and increased gradually until reaching 30 mints per time.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

participants with a body mass index (BMI) 30-40 kg/m2, whose age ranged between 30 and 45 years, mild to moderate fatty liver (Liver to Spleen ratio \< 1), and with waist hip ratio (WHR) greater than 0.8 for females and greater than 0.95 for males were included

Exclusion criteria

abdominal hernias, severe diabetes or autoimmune diseases; patients with osteoporosis, phlebitis and thrombophlebitis; patients with metallic sections, articular prosthesis, intrauterine devices or a pacemaker; pregnant women; patients with a reduced nervous sensibility or with neurological pathologies; patients with obliterating arteriopathies and patients with important inflammatory processes or neoplastic diseases

Design outcomes

Primary

MeasureTime frameDescription
Abdominal subcutaneous and visceral fats volume measured by Computed tomography.three monthsThe abdominal fat volume will be measured by a new advanced application which called Synapse 3D Lung and Abdomen Analysis.

Secondary

MeasureTime frameDescription
Liver to Spleen ratio (L/S ratio)three monthsmeasurement of liver attenuation in Hounsfield units (LA) by multidetector CT scans of the abdomen at the level of the T12 to L1 intervertebral space and was used to estimate fatty liver (low LA=high fatty liver). The LA was determined by calculating the mean Hounsfield units of 3 regions of interest in the parenchyma of the right lobe of the liver

Other

MeasureTime frame
height in meters and waist to hip ratio (WHR),three months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026