Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity

Obesity Clinical Trial

— UATC  

Official title:

Ultrasound-induced Adipose Tissue Cavitation: Effects on Cardiometabolic Risk and Body Composition in Persons With Obesity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04417816
• Other study ID #: UATC-001
• Status: Terminated
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: August 2021
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Exercise training intervention with ultrasound induced adipose tissue cavitation
Exercise training intervention with ultrasound induced adipose tissue cavitation
• Exercise training intervention without ultrasound induced adipose tissue cavitation
Exercise training intervention with ultrasound induced adipose tissue cavitation

Locations

Country	Name	City	State
Belgium	Hasselt University	Diepenbeek

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DEXA scan	Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)	baseline
Primary	DEXA scan	Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)	week 12
Primary	Fasting blood sample	(glycated haemoglobin)	Baseline
Primary	Fasting blood sample	(glycated haemoglobin)	week 12
Primary	lipid profile	total LDL, HDL, triglycerides	Baseline
Primary	lipid profile	total LDL, HDL, triglycerides	week 12
Primary	kidney function	urea, creatinine	Baseline
Primary	kidney function	urea, creatinine	week 12
Primary	inflammation	CRP	Baseline
Primary	inflammation	CRP	week 12
Primary	Bloodpressure	systolic and diastolic blood pressure	Baseline
Primary	Bloodpressure	systolic and diastolic blood pressure	Week 12
Primary	oral glucose tolerance test	glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load	Baseline
Primary	oral glucose tolerance test	glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load	week 12
Secondary	Overall physical fitness	Maximal oxygen uptake (during cardiopulmonary exercise testing)	Baseline
Secondary	Overall physical fitness	Maximal oxygen uptake (during cardiopulmonary exercise testing)	week 12
Secondary	Overall physical fitness	Maximal resistance (during cardiopulmonary exercise testing)	Baseline
Secondary	Overall physical fitness	Maximal resistance (during cardiopulmonary exercise testing)	week 12
Secondary	Overall physical fitness	Maximal heart rate (measured by electrocardiogram)	Baseline
Secondary	Overall physical fitness	Maximal heart rate (measured by electrocardiogram)	week 12
Secondary	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	Baseline
Secondary	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	week 12
Secondary	Food intake	3-day food diary	Baseline
Secondary	Food intake	3-day food diary	week 12