Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Other: Exercise training intervention without ultrasound induced adipose tissue cavitation; Other: Exercise training intervention with ultrasound induced adipose tissue cavitation

• Registration Number: NCT04417816
• Lead Sponsor: Hasselt University

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 available

Study Timeline

• Study Start: 2018-04-15
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise training + sham procedure	Exercise training intervention without ultrasound induced adipose tissue cavitation	-
Exercise training + adipose tissue cavitation	Exercise training intervention with ultrasound induced adipose tissue cavitation	-

Primary Outcome Measures

Name	Time	Method
kidney function	week 12	urea, creatinine
Fasting blood sample	week 12	(glycated haemoglobin)
oral glucose tolerance test	week 12	glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load
DEXA scan	week 12	Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
lipid profile	week 12	total LDL, HDL, triglycerides
Bloodpressure	Week 12	systolic and diastolic blood pressure
inflammation	week 12	CRP

Secondary Outcome Measures

Name	Time	Method
Overall physical fitness	week 12	Maximal heart rate (measured by electrocardiogram)
SF-36 questionaire	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	week 12	3-day food diary

Trial Locations

Locations (1)

Hasselt University; 🇧🇪 Diepenbeek, Belgium