NCT04417816

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

May 15, 2020

Last Update Submit

August 24, 2021

Conditions

Obesity

Outcome Measures

Primary Outcomes (14)

  • DEXA scan

    Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)

    baseline

  • DEXA scan

    Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)

    week 12

  • Fasting blood sample

    (glycated haemoglobin)

    Baseline

  • Fasting blood sample

    (glycated haemoglobin)

    week 12

  • lipid profile

    total LDL, HDL, triglycerides

    Baseline

  • lipid profile

    total LDL, HDL, triglycerides

    week 12

  • kidney function

    urea, creatinine

    Baseline

  • kidney function

    urea, creatinine

    week 12

  • inflammation

    CRP

    Baseline

  • inflammation

    CRP

    week 12

  • Bloodpressure

    systolic and diastolic blood pressure

    Baseline

  • Bloodpressure

    systolic and diastolic blood pressure

    Week 12

  • oral glucose tolerance test

    glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load

    Baseline

  • oral glucose tolerance test

    glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load

    week 12

Secondary Outcomes (10)

  • Overall physical fitness

    Baseline

  • Overall physical fitness

    week 12

  • Overall physical fitness

    Baseline

  • Overall physical fitness

    week 12

  • Overall physical fitness

    Baseline

  • +5 more secondary outcomes

Study Arms (2)

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

Interventions

Exercise training intervention with ultrasound induced adipose tissue cavitationOTHER

Exercise training intervention with ultrasound induced adipose tissue cavitation

Exercise training + adipose tissue cavitation
Exercise training intervention without ultrasound induced adipose tissue cavitationOTHER

Exercise training intervention with ultrasound induced adipose tissue cavitation

Exercise training + sham procedure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male/female (1:1),
  • age 18-65 y,
  • abdominal obesity (waist circumference \>102cm or \>88cm) -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, 3590, Belgium

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dominique Hansen, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR

  • Kenneth Verboven, dr.

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2020

First Posted

June 5, 2020

Study Start

April 15, 2018

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations

BE(1)