Clinical trial NCT04161703: Effect of Focused Ultrasound on Abdominal and Intrahepatic Fat in Patients With Non-alcoholic Fatty Liver Disease
Official title: Effect of Focused Ultrasound on Abdominal and Intrahepatic Fat in Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Abdominal subcutaneous and visceral fats volume measured by Computed tomography.
timeFrame: three months
Secondary outcomes:
measure: Liver to Spleen ratio (L/S ratio)
timeFrame: three months
Other outcomes:
measure: height in meters and waist to hip ratio (WHR),
timeFrame: three months
Locations:
city: Cairo
country: Egypt
facility: Kasr Alaini
Study officials:
affiliation: Cairo University
name: Mona M Taha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.