Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Other: Exercise training intervention with ultrasound induced adipose tissue cavitation
* Other: Exercise training intervention without ultrasound induced adipose tissue cavitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training + adipose tissue cavitation<br> | Other: Exercise training intervention with ultrasound induced adipose tissue cavitation<br>* Exercise training intervention with ultrasound induced adipose tissue cavitation<br>|
| Sham Comparator: Exercise training + sham procedure<br> | Other: Exercise training intervention without ultrasound induced adipose tissue cavitation<br>* Exercise training intervention with ultrasound induced adipose tissue cavitation<br>|

What is the study measuring?
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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 |