Metabolic Dysregulation as the Underlying Principle of Integrated Pathophysiology of Obesity-associated Chronic Diseases: Molecular Landscape of Complex Lifestyle Modification
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Metabolic flexibility in response to submaximal exercise and nutritional challenge
研究概览
简要总结
The goal of this clinical trial is to detect the impact of the 3-month complex lifestyle intervention, consisting of dietary counselling, supervised exercise training and cognitive-behavioural intervention in middle-aged sedentary individuals with obesity, specific questions are:
- What is the adaptive response to exercise training on the whole-body and skeletal muscle energy metabolism, insulin sensitivity, metabolic flexibility, muscle functional parameters and cardiopulmonary fitness?
- Would the intensity-related changes of the exercise-induced substrate preference (lipids vs carbohydrates) be a good predictive marker of metabolic flexibility i.e. the capacity to reduce the whole-body metabolic burden in patients with obesity?
- Is the signal driving the adaptive response to regular exercise contained in serum derived Extracellular vesicles?
Researchers will examine effects of exercise training intervention on whole body energy metabolism, by integrating clinical, biochemical and molecular data.
Participants will:
- Undergo 3 months exercise - intervention program.
- Be submitted to examination of their obesity, energy metabolism and cardiopulmonary fitness related phenotypes using bioelectric impedance, indirect calorimetry, cycle spiroergometry.
- Blood samples will be taken both, at the baseline PRE- and POST- intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 30-45 kg.m-2 -
排除标准
- •smoking, cancer,
结局指标
主要结局
Metabolic flexibility in response to submaximal exercise and nutritional challenge
时间窗: 24 months
Metabolic flexibility (metabolic substrate switching) will be measured using indirect calorimetry during submaximal exercise test (on stationary bike) and in response to nutritional challenge (fasting / glucose uptake during oGTT)
次要结局
- cardiopulmonary fitness (VO2max)(24 months)
- Index of insulin resistance (oGTT)(24 months)
- abdominal adiposity and abdominal adipose tissue distribution (subcutaneous / visceral)(24 months)
研究者
Jozef Ukropec
PhD, DSc
Slovak Academy of Sciences
