Clinical trial NCT04417816: Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity
Official title: Ultrasound-induced Adipose Tissue Cavitation: Effects on Cardiometabolic Risk and Body Composition in Persons With Obesity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: DEXA scan
timeFrame: baseline
measure: DEXA scan
timeFrame: week 12
measure: Fasting blood sample
timeFrame: Baseline
measure: Fasting blood sample
timeFrame: week 12
measure: lipid profile
timeFrame: Baseline
measure: lipid profile
timeFrame: week 12
measure: kidney function
timeFrame: Baseline
measure: kidney function
timeFrame: week 12
measure: inflammation
timeFrame: Baseline
measure: inflammation
timeFrame: week 12
measure: Bloodpressure
timeFrame: Baseline
measure: Bloodpressure
timeFrame: Week 12
measure: oral glucose tolerance test
timeFrame: Baseline
measure: oral glucose tolerance test
timeFrame: week 12
Secondary outcomes:
measure: Overall physical fitness
timeFrame: Baseline
measure: Overall physical fitness
timeFrame: week 12
measure: Overall physical fitness
timeFrame: Baseline
measure: Overall physical fitness
timeFrame: week 12
measure: Overall physical fitness
timeFrame: Baseline
measure: Overall physical fitness
timeFrame: week 12
measure: SF-36 questionaire
timeFrame: Baseline
measure: SF-36 questionaire
timeFrame: week 12
measure: Food intake
timeFrame: Baseline
measure: Food intake
timeFrame: week 12
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Dominique Hansen, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Kenneth Verboven, dr.
role: STUDY_CHAIR
References: