Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity

NCT ID: NCT04417816

Last Updated: 2021-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2020-02-28

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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Exercise training + adipose tissue cavitation

Group Type EXPERIMENTAL

Exercise training intervention with ultrasound induced adipose tissue cavitation

Intervention Type OTHER

Exercise training intervention with ultrasound induced adipose tissue cavitation

Exercise training + sham procedure

Group Type SHAM_COMPARATOR

Exercise training intervention without ultrasound induced adipose tissue cavitation

Intervention Type OTHER

Exercise training intervention with ultrasound induced adipose tissue cavitation

Interventions

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Exercise training intervention with ultrasound induced adipose tissue cavitation

Exercise training intervention with ultrasound induced adipose tissue cavitation

Intervention Type OTHER

Exercise training intervention without ultrasound induced adipose tissue cavitation

Exercise training intervention with ultrasound induced adipose tissue cavitation

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Dominique Hansen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dominique Hansen, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Kenneth Verboven, dr.

Role: STUDY_CHAIR

Hasselt University

Locations

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Hasselt University

Diepenbeek, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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UATC-001

Identifier Type: -

Identifier Source: org_study_id

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