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At the request of the Ethical Committee
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training + adipose tissue cavitation | Experimental |
| |
| Exercise training + sham procedure | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training intervention with ultrasound induced adipose tissue cavitation | Other | Exercise training intervention with ultrasound induced adipose tissue cavitation |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique Hansen, prof. dr. | Hasselt University | Principal Investigator |
| Kenneth Verboven, dr. | Hasselt University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasselt University | Diepenbeek | 3590 | Belgium |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Exercise training intervention without ultrasound induced adipose tissue cavitation | Other | Exercise training intervention with ultrasound induced adipose tissue cavitation |
|
| 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 |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |