Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity (UATC)

Ultrasound-induced Adipose Tissue Cavitation: Effects on Cardiometabolic Risk and Body Composition in Persons With Obesity

The addition of ultrasound-induced adipose tissue cavitation (UATC) at the level of the abdominal subcutaneous adipose tissue may seem relevant as an additive treatment option to exercise intervention in individuals with obesity. However, whether individuals with obesity who participate in an exercise intervention and additionally undergo UATC, are more likely to develop a metabolically healthy phenotype, as opposed to subjects with obesity undergoing exercise training or UATC only, remains to be studied. Therefore, the first aim of this study is to examine the impact of combined UATC during exercise intervention on abdominal subcutaneous and whole-body adipose tissue mass, quality of life and cardiometabolic risk in individuals with abdominal obesity.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Other: Exercise training intervention with ultrasound induced adipose tissue cavitation; Other: Exercise training intervention without ultrasound induced adipose tissue cavitation

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Diepenbeek, Belgium, 3590
    • Hasselt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male/female (1:1),
• age 18-65 y,
• abdominal obesity (waist circumference >102cm or >88cm) -

Exclusion Criteria:

• involvement in dietary or exercise intervention in the last year,
• intake of any medication,
• clinically diagnosed diseases (cardiovascular disease, hypertension, venous thromboses blood diseases, presence of a pacemaker/defibrillator, brain or nervous system diseases, kidney, thyroid or liver disease, chronic inflammatory diseases, cancer, osteoporosis and epilepsy).
• Persons with a pregnancy,
• a recent bone injury or the presence of a metal prothese

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise training + adipose tissue cavitation	Other: Exercise training intervention with ultrasound induced adipose tissue cavitation; Exercise training intervention with ultrasound induced adipose tissue cavitation
Sham Comparator: Exercise training + sham procedure	Other: Exercise training intervention without ultrasound induced adipose tissue cavitation; Exercise training intervention with ultrasound induced adipose tissue cavitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DEXA scan	Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)	baseline
DEXA scan	Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)	week 12
Fasting blood sample	(glycated haemoglobin)	Baseline
Fasting blood sample	(glycated haemoglobin)	week 12
lipid profile	total LDL, HDL, triglycerides	Baseline
lipid profile	total LDL, HDL, triglycerides	week 12
kidney function	urea, creatinine	Baseline
kidney function	urea, creatinine	week 12
inflammation	CRP	Baseline
inflammation	CRP	week 12
Bloodpressure	systolic and diastolic blood pressure	Baseline
Bloodpressure	systolic and diastolic blood pressure	Week 12
oral glucose tolerance test	glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load	Baseline
oral glucose tolerance test	glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall physical fitness	Maximal oxygen uptake (during cardiopulmonary exercise testing)	Baseline
Overall physical fitness	Maximal oxygen uptake (during cardiopulmonary exercise testing)	week 12
Overall physical fitness	Maximal resistance (during cardiopulmonary exercise testing)	Baseline
Overall physical fitness	Maximal resistance (during cardiopulmonary exercise testing)	week 12
Overall physical fitness	Maximal heart rate (measured by electrocardiogram)	Baseline
Overall physical fitness	Maximal heart rate (measured by electrocardiogram)	week 12
SF-36 questionaire	Quality of Life questionaire, a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status	Baseline
SF-36 questionaire	Quality of Life questionaire, a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status	week 12
Food intake	3-day food diary	Baseline
Food intake	3-day food diary	week 12

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Study Chair: Kenneth Verboven, dr., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: UATC-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No