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ACTIVE NOT RECRUITING
NCT06954298
NA

Molecular Landscape of Complex Lifestyle Modification

Sponsor: Slovak Academy of Sciences

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

20 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-12-15

Completion Date

2026-06-30

Last Updated

2025-05-01

Healthy Volunteers

No

Interventions

BEHAVIORAL

supervised lifestyle modification

Supervised lifestyle intervention will consist of regular exercise (3x a week), nutritional counselling (weekly), cognitive bahavioural therapy (monthly).

Locations (1)

Center for Obesity Management EASO, Biomedical Research Center SAS

Bratislava, Bratislava Region, Slovakia