ObesityUATCNCT04417816
Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity
A study testing Exercise training intervention with ultrasound induced adipose tissue cavitation and Exercise training intervention without ultrasound induced adipose tissue cavitation in people with Obesity, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise training intervention with ultrasound induced adipose tissue cavitation and Exercise training intervention without ultrasound induced adipose tissue cavitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Apr 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male/female (1:1),
- age 18-65 y,
- abdominal obesity (waist circumference >102cm or >88cm) -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Exercise training intervention with ultrasound induced adipose tissue cavitation, Exercise training intervention without ultrasound induced adipose tissue cavitation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training intervention with ultrasound induced adipose tissue cavitationOther
Exercise training intervention with ultrasound induced adipose tissue cavitation
Exercise training intervention without ultrasound induced adipose tissue cavitationOther
Exercise training intervention with ultrasound induced adipose tissue cavitation
| Study group | Role | What they receive |
|---|---|---|
| Exercise training + adipose tissue cavitation | Experimental | Not described Receives: Other: Exercise training intervention with ultrasound induced adipose tissue cavitation |
| Exercise training + sham procedure | Sham comparator | Not described Receives: Other: Exercise training intervention without ultrasound induced adipose tissue cavitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
DEXA scan
Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
Measured: baseline
DEXA scan
Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
Measured: week 12
Fasting blood sample
(glycated haemoglobin)
Measured: Baseline
Fasting blood sample
(glycated haemoglobin)
Measured: week 12
lipid profile
total LDL, HDL, triglycerides
Measured: Baseline
lipid profile
total LDL, HDL, triglycerides
Measured: week 12
kidney function
urea, creatinine
Measured: Baseline
kidney function
urea, creatinine
Measured: week 12
inflammation
CRP
Measured: Baseline
inflammation
CRP
Measured: week 12
Bloodpressure
systolic and diastolic blood pressure
Measured: Baseline
Bloodpressure
systolic and diastolic blood pressure
Measured: Week 12
oral glucose tolerance test
glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load
Measured: Baseline
oral glucose tolerance test
glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load
Measured: week 12
Secondary outcomes (10)
Overall physical fitness
Maximal oxygen uptake (during cardiopulmonary exercise testing)
Measured: Baseline
Overall physical fitness
Maximal oxygen uptake (during cardiopulmonary exercise testing)
Measured: week 12
Overall physical fitness
Maximal resistance (during cardiopulmonary exercise testing)
Measured: Baseline
Overall physical fitness
Maximal resistance (during cardiopulmonary exercise testing)
Measured: week 12
Overall physical fitness
Maximal heart rate (measured by electrocardiogram)
Measured: Baseline
Overall physical fitness
Maximal heart rate (measured by electrocardiogram)
Measured: 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
Measured: 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
Measured: week 12
Food intake
3-day food diary
Measured: Baseline
Food intake
3-day food diary
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start15 Apr 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Why it stopped: At the request of the Ethical Committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Dominique Hansen, prof. dr., Principal investigator, Hasselt UniversityKenneth Verboven, dr., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417816
- Sponsor's protocol ID
- UATC-001
- Acronym
- UATC
- Status last verified
- Aug 2021
- First submitted
- 15 May 2020
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-induced Adipose Tissue Cavitation: Effects on Cardiometabolic Risk and Body Composition in Persons With Obesity
- ClinicalTrials.gov ID
- NCT04417816
- Acronym / sponsor ID
- UATC / UATC-001
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At the request of the Ethical Committee
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training + adipose tissue cavitation | Experimental | Other: Exercise training intervention with ultrasound induced adipose tissue cavitation |
| Exercise training + sham procedure | Sham comparator | Other: Exercise training intervention without ultrasound induced adipose tissue cavitation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male/female (1:1),
- age 18-65 y,
- abdominal obesity (waist circumference >102cm or >88cm) -
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training intervention with ultrasound induced adipose tissue cavitationExercise training intervention with ultrasound induced adipose tissue cavitation | Other | Exercise training + adipose tissue cavitation |
| Exercise training intervention without ultrasound induced adipose tissue cavitationExercise training intervention with ultrasound induced adipose tissue cavitation | Other | Exercise training + sham procedure |
Primary outcome
DEXA scan
Time frame: baseline
Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
DEXA scan
Time frame: week 12
Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
Fasting blood sample
Time frame: Baseline
(glycated haemoglobin)
Fasting blood sample
Time frame: week 12
(glycated haemoglobin)
lipid profile
Time frame: Baseline
total LDL, HDL, triglycerides
lipid profile
Time frame: week 12
total LDL, HDL, triglycerides
kidney function
Time frame: Baseline
urea, creatinine
kidney function
Time frame: week 12
urea, creatinine
inflammation
Time frame: Baseline
CRP
inflammation
Time frame: week 12
CRP
Bloodpressure
Time frame: Baseline
systolic and diastolic blood pressure
Bloodpressure
Time frame: Week 12
systolic and diastolic blood pressure
oral glucose tolerance test
Time frame: Baseline
glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load
oral glucose tolerance test
Time frame: week 12
glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load
10 secondary outcomes
Overall physical fitness
Time frame: Baseline
Overall physical fitness
Time frame: week 12
Overall physical fitness
Time frame: Baseline
Overall physical fitness
Time frame: week 12
Overall physical fitness
Time frame: Baseline
Overall physical fitness
Time frame: week 12
SF-36 questionaire
Time frame: Baseline
SF-36 questionaire
Time frame: week 12
Food intake
Time frame: Baseline
Food intake
Time frame: week 12
Results and safety
The study was stopped early (reason given: At the request of the Ethical Committee). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Hansen, prof. dr. principal investigator
Hasselt University
Kenneth Verboven, dr. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training intervention with ultrasound induced adipose tissue cavitation and Exercise training intervention without ultrasound induced adipose tissue cavitation in people with Obesity, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: At the request of the Ethical Committee). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DEXA scan (time frame: baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.