Ultrasound-induced Adipose Tissue Cavitation: Effects on Cardiometabolic Risk and Body Composition in Persons With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- kidney function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male/female (1:1),
- •age 18-65 y,
- •abdominal obesity (waist circumference >102cm or >88cm) -
排除标准
- •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
结局指标
主要结局
kidney function
时间窗: week 12
urea, creatinine
Fasting blood sample
时间窗: week 12
(glycated haemoglobin)
oral glucose tolerance test
时间窗: week 12
glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load
DEXA scan
时间窗: week 12
Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
lipid profile
时间窗: week 12
total LDL, HDL, triglycerides
Bloodpressure
时间窗: Week 12
systolic and diastolic blood pressure
inflammation
时间窗: week 12
CRP
次要结局
- SF-36 questionaire(week 12)
- Food intake(week 12)
- Overall physical fitness(week 12)
研究者
Dominique Hansen
Principal Investigator
Hasselt University