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Clinical Trials/NCT04161703
NCT04161703
Completed
Not Applicable

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

Cairo University1 site in 1 country50 target enrollmentNovember 20, 2019
ConditionsFatty Liver

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fatty Liver
Sponsor
Cairo University
Enrollment
50
Locations
1
Primary Endpoint
Abdominal subcutaneous and visceral fats volume measured by Computed tomography.
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2019
End Date
March 20, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mona Mohamed Taha

ASSISTANT PROFESSOR

Cairo University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Abdominal subcutaneous and visceral fats volume measured by Computed tomography.

Time Frame: three months

The abdominal fat volume will be measured by a new advanced application which called "Synapse 3D Lung and Abdomen Analysis".

Secondary Outcomes

  • Liver to Spleen ratio (L/S ratio)(three months)

Study Sites (1)

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