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Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity (UATC)

Primary Purpose

Obesity

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Exercise training intervention with ultrasound induced adipose tissue cavitation
Exercise training intervention without ultrasound induced adipose tissue cavitation
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hasselt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Exercise training + adipose tissue cavitation

Exercise training + sham procedure

Arm Description

Outcomes

Primary Outcome Measures

DEXA scan
Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
DEXA scan
Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
Fasting blood sample
(glycated haemoglobin)
Fasting blood sample
(glycated haemoglobin)
lipid profile
total LDL, HDL, triglycerides
lipid profile
total LDL, HDL, triglycerides
kidney function
urea, creatinine
kidney function
urea, creatinine
inflammation
CRP
inflammation
CRP
Bloodpressure
systolic and diastolic blood pressure
Bloodpressure
systolic and diastolic blood pressure
oral glucose tolerance test
glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load
oral glucose tolerance test
glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load

Secondary Outcome Measures

Overall physical fitness
Maximal oxygen uptake (during cardiopulmonary exercise testing)
Overall physical fitness
Maximal oxygen uptake (during cardiopulmonary exercise testing)
Overall physical fitness
Maximal resistance (during cardiopulmonary exercise testing)
Overall physical fitness
Maximal resistance (during cardiopulmonary exercise testing)
Overall physical fitness
Maximal heart rate (measured by electrocardiogram)
Overall physical fitness
Maximal heart rate (measured by electrocardiogram)
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
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
Food intake
3-day food diary
Food intake
3-day food diary

Full Information

First Posted
May 15, 2020
Last Updated
August 24, 2021
Sponsor
Hasselt University
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1. Study Identification

Unique Protocol Identification Number
NCT04417816
Brief Title
Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity
Acronym
UATC
Official Title
Ultrasound-induced Adipose Tissue Cavitation: Effects on Cardiometabolic Risk and Body Composition in Persons With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
At the request of the Ethical Committee
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training + adipose tissue cavitation
Arm Type
Experimental
Arm Title
Exercise training + sham procedure
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Exercise training intervention with ultrasound induced adipose tissue cavitation
Intervention Description
Exercise training intervention with ultrasound induced adipose tissue cavitation
Intervention Type
Other
Intervention Name(s)
Exercise training intervention without ultrasound induced adipose tissue cavitation
Intervention Description
Exercise training intervention with ultrasound induced adipose tissue cavitation
Primary Outcome Measure Information:
Title
DEXA scan
Description
Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
Time Frame
baseline
Title
DEXA scan
Description
Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
Time Frame
week 12
Title
Fasting blood sample
Description
(glycated haemoglobin)
Time Frame
Baseline
Title
Fasting blood sample
Description
(glycated haemoglobin)
Time Frame
week 12
Title
lipid profile
Description
total LDL, HDL, triglycerides
Time Frame
Baseline
Title
lipid profile
Description
total LDL, HDL, triglycerides
Time Frame
week 12
Title
kidney function
Description
urea, creatinine
Time Frame
Baseline
Title
kidney function
Description
urea, creatinine
Time Frame
week 12
Title
inflammation
Description
CRP
Time Frame
Baseline
Title
inflammation
Description
CRP
Time Frame
week 12
Title
Bloodpressure
Description
systolic and diastolic blood pressure
Time Frame
Baseline
Title
Bloodpressure
Description
systolic and diastolic blood pressure
Time Frame
Week 12
Title
oral glucose tolerance test
Description
glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load
Time Frame
Baseline
Title
oral glucose tolerance test
Description
glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Overall physical fitness
Description
Maximal oxygen uptake (during cardiopulmonary exercise testing)
Time Frame
Baseline
Title
Overall physical fitness
Description
Maximal oxygen uptake (during cardiopulmonary exercise testing)
Time Frame
week 12
Title
Overall physical fitness
Description
Maximal resistance (during cardiopulmonary exercise testing)
Time Frame
Baseline
Title
Overall physical fitness
Description
Maximal resistance (during cardiopulmonary exercise testing)
Time Frame
week 12
Title
Overall physical fitness
Description
Maximal heart rate (measured by electrocardiogram)
Time Frame
Baseline
Title
Overall physical fitness
Description
Maximal heart rate (measured by electrocardiogram)
Time Frame
week 12
Title
SF-36 questionaire
Description
Quality of Life questionaire, a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status
Time Frame
Baseline
Title
SF-36 questionaire
Description
Quality of Life questionaire, a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status
Time Frame
week 12
Title
Food intake
Description
3-day food diary
Time Frame
Baseline
Title
Food intake
Description
3-day food diary
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Hansen, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Verboven, dr.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Hasselt University
City
Diepenbeek
ZIP/Postal Code
3590
Country
Belgium

12. IPD Sharing Statement

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Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity

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