Center for Obesity Management EASO, Biomedical Research Center SAS
Bratislava, Bratislava Region, 84505, Slovakia
NCT Number: NCT06954298
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.
This study is active but is not currently recruiting participants.
Notify Me20 year–50 year
All sexes
Interventional
Not applicable
Bratislava, Bratislava Region, 84505, Slovakia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
BMI 30-45 kg.m-2 -
Exclusion criteria
smoking, cancer,
-
Supervised lifestyle intervention will consist of regular exercise (3x a week), nutritional counselling (weekly), cognitive bahavioural therapy (monthly).
Time frame: 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)
Time frame: 24 months
Cardiopulmonary fitness will be measured by bicycle spiro-ergometry
Time frame: 24 months
Index of insulin resistance will be calculated from the results of the frequently sampled oral glucose tolerance test oGTT.
Time frame: 24 months
abdominal adiposity will be assessed by quadrupedal biopimpedance, and adipose tissue distribution by magnetic resonance imagining
Slovak Academy of Sciences
Other Gov
Metabolic Dysregulation as the Underlying Principle of Integrated Pathophysiology of Obesity-associated Chronic Diseases: Molecular Landscape of Complex Lifestyle Modification
Acronym: COPMose
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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