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NCT Number: NCT06954298

Molecular Landscape of Complex Lifestyle Modification

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Obesity Management EASO, Biomedical Research Center SAS

Bratislava, Bratislava Region, 84505, Slovakia

Who can participate

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,

-

Treatment and study plan

supervised lifestyle modification

Behavioral

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

Primary outcomes

  1. Metabolic flexibility in response to submaximal exercise and nutritional challenge

    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)

Secondary outcomes

  1. cardiopulmonary fitness (VO2max)

    Time frame: 24 months

    Cardiopulmonary fitness will be measured by bicycle spiro-ergometry

  2. Index of insulin resistance (oGTT)

    Time frame: 24 months

    Index of insulin resistance will be calculated from the results of the frequently sampled oral glucose tolerance test oGTT.

  3. abdominal adiposity and abdominal adipose tissue distribution (subcutaneous / visceral)

    Time frame: 24 months

    abdominal adiposity will be assessed by quadrupedal biopimpedance, and adipose tissue distribution by magnetic resonance imagining

Sponsors and collaborators

Lead sponsor

Slovak Academy of Sciences

Other Gov

Collaborators

  • Medical University Vienna

Registry information

Official study title

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

Acronym: COPMose

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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