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

NCT04161703 | Completed DMC

• 1 other identifier: P.T REC/012/00451.
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Liver to Spleen ratio (L/S ratio)

  three months

Other Outcomes (1)

• height in meters and waist to hip ratio (WHR),

  three months

Study Arms (2)

focused ultrasound, diet and exercises

EXPERIMENTAL

Procedure: focused ultrasound, diet and exercise

diet and exercises

EXPERIMENTAL

Procedure: diet and exercise

Interventions

focused ultrasound, diet and exercise PROCEDURE

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

focused ultrasound, diet and exercises

diet and exercise PROCEDURE

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.

diet and exercises

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alaini

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33909662 DERIVED

MeSH Terms

Conditions

Fatty Liver

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mona M Taha, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: November 9, 2019
• First Posted: November 13, 2019
• Study Start: November 20, 2019
• Primary Completion: February 20, 2020
• Study Completion: March 20, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)