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

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.

Study Overview

• Status: Completed
• Conditions: Fatty Liver
• Intervention / Treatment: Procedure: focused ultrasound, diet and exercise; Procedure: diet and exercise

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Alaini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: focused ultrasound, diet and exercises	Procedure: focused 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
EXPERIMENTAL: diet and exercises	Procedure: diet 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal subcutaneous and visceral fats volume measured by Computed tomography.	The abdominal fat volume will be measured by a new advanced application which called "Synapse 3D Lung and Abdomen Analysis".	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver to Spleen ratio (L/S ratio)	measurement 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	three months

Other Outcome Measures

Outcome Measure	Time Frame
height in meters and waist to hip ratio (WHR),	three months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mona M Taha, PhD, Cairo University

Publications and helpful links

General Publications

• Taha MM, Aneis YM, Mohamady HM, S A A, Elsayed SH. Effect of focused ultrasound cavitation augmented with aerobic exercise on abdominal and intrahepatic fat in patients with non-alcoholic fatty liver disease: A randomized controlled trial. PLoS One. 2021 Apr 28;16(4):e0250337. doi: 10.1371/journal.pone.0250337. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2019
• Primary Completion (ACTUAL): February 20, 2020
• Study Completion (ACTUAL): March 20, 2020

Study Registration Dates

• First Submitted: November 9, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (ACTUAL): November 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: P.T REC/012/00451.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No