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临床试验/NCT06954298
NCT06954298进行中(未招募)不适用

Metabolic Dysregulation as the Underlying Principle of Integrated Pathophysiology of Obesity-associated Chronic Diseases: Molecular Landscape of Complex Lifestyle Modification

Slovak Academy of Sciences2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月15日最近更新:
适应症

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

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jozef Ukropec

PhD, DSc

Slovak Academy of Sciences

研究点 (2)

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