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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417816
Recruitment Status : Terminated (At the request of the Ethical Committee)
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Dominique Hansen, Hasselt University

Tracking Information
First Submitted Date  ICMJE May 15, 2020
First Posted Date  ICMJE June 5, 2020
Last Update Posted Date June 5, 2020
Actual Study Start Date  ICMJE April 15, 2018
Actual Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • Body composition [ Time Frame: baseline ]
    DEXA scan (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
  • Body composition [ Time Frame: week 12 ]
    DEXA scan (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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • Overall physical fitness [ Time Frame: Baseline ]
    Maximal oxygen uptake (during cardiopulmonary exercise testing)
  • Overall physical fitness [ Time Frame: week 12 ]
    Maximal oxygen uptake (during cardiopulmonary exercise testing)
  • Overall physical fitness [ Time Frame: Baseline ]
    Maximal resistance (during cardiopulmonary exercise testing)
  • Overall physical fitness [ Time Frame: week 12 ]
    Maximal resistance (during cardiopulmonary exercise testing)
  • Overall physical fitness [ Time Frame: Baseline ]
    Maximal heart rate (measured by electrocardiogram)
  • Overall physical fitness [ Time Frame: week 12 ]
    Maximal heart rate (measured by electrocardiogram)
  • SF-36 questionaire [ Time Frame: Baseline ]
    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 [ Time Frame: week 12 ]
    Quality of Life questionaire, a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status
  • Food intake [ Time Frame: Baseline ]
    3-day food diary
  • Food intake [ Time Frame: week 12 ]
    3-day food diary
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity
Official Title  ICMJE Ultrasound-induced Adipose Tissue Cavitation: Effects on Cardiometabolic Risk and Body Composition in Persons With Obesity
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Obesity
Intervention  ICMJE
  • Other: Exercise training intervention with ultrasound induced adipose tissue cavitation
    Exercise training intervention with ultrasound induced adipose tissue cavitation
  • Other: Exercise training intervention without ultrasound induced adipose tissue cavitation
    Exercise training intervention with ultrasound induced adipose tissue cavitation
Study Arms  ICMJE
  • Experimental: Exercise training + adipose tissue cavitation
    Intervention: Other: Exercise training intervention with ultrasound induced adipose tissue cavitation
  • Sham Comparator: Exercise training + sham procedure
    Intervention: Other: Exercise training intervention without ultrasound induced adipose tissue cavitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 2, 2020)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2020
Actual Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04417816
Other Study ID Numbers  ICMJE UATC-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dominique Hansen, Hasselt University
Study Sponsor  ICMJE Hasselt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dominique Hansen, prof. dr. Hasselt University
Study Chair: Kenneth Verboven, dr. Hasselt University
PRS Account Hasselt University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP