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

Not Applicable

Completed

• Conditions: Fatty Liver
• Interventions: Procedure: diet and exercise; Procedure: focused ultrasound, diet and exercise

• Registration Number: NCT04161703
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-09
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-13
• Study Start: 2019-11-20
• Primary Completion: 2020-02-20
• Study Completion: 2020-03-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diet and exercises	diet and exercise	-
focused ultrasound, diet and exercises	focused ultrasound, diet and exercise	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Liver to Spleen ratio (L/S ratio)	three months	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

Trial Locations

Locations (1)

Kasr Alaini; 🇪🇬 Cairo, Egypt