Fatty Liver Clinical Trial
Official title:
Effect of Focused Ultrasound on Abdominal and Intrahepatic Fat in Patients With Non-alcoholic Fatty Liver Disease
Verified date | April 2020 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 20, 2020 |
Est. primary completion date | February 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr Alaini | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | height in meters and waist to hip ratio (WHR), | three months | ||
Primary | 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 | 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 |
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