Obesity PreventionCOPMoseNCT06954298
Molecular Landscape of Complex Lifestyle Modification
A study testing supervised lifestyle modification in people with Obesity Prevention and Obesity, run by Slovak Academy of Sciences at 1 site in Slovakia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Obesity Prevention, Obesity, Metabolic Disease
- What is being tested?
- supervised lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 Dec 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Center for Obesity Management EASO, Biomedical Research Center SAS
Bratislava, Bratislava Region, 84505
About this study
Official title: Metabolic Dysregulation as the Underlying Principle of Integrated Pathophysiology of Obesity-associated Chronic Diseases: 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?
Read more
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.
- Conditions
- Obesity Prevention, Obesity, Metabolic Disease
- Being tested
- supervised lifestyle modification
- Keywords
- lifestyle intervention, exerkines, metabolic flexibility
- Medical subject headings
- Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised lifestyle modificationBehavioural
Supervised lifestyle intervention will consist of regular exercise (3x a week), nutritional counselling (weekly), cognitive bahavioural therapy (monthly).
| Study group | Role | What they receive |
|---|---|---|
| lifestyle intervention | Experimental | Not described Receives: Behavioral: supervised lifestyle modification |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic flexibility in response to submaximal exercise and nutritional challenge
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)
Measured: 24 months
Secondary outcomes (3)
cardiopulmonary fitness (VO2max)
Cardiopulmonary fitness will be measured by bicycle spiro-ergometry
Measured: 24 months
Index of insulin resistance (oGTT)
Index of insulin resistance will be calculated from the results of the frequently sampled oral glucose tolerance test oGTT.
Measured: 24 months
abdominal adiposity and abdominal adipose tissue distribution (subcutaneous / visceral)
abdominal adiposity will be assessed by quadrupedal biopimpedance, and adipose tissue distribution by magnetic resonance imagining
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slovak Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Medical University of Vienna
- Responsible party
- Principal investigator, Jozef Ukropec, Slovak Academy of Sciences
- Investigators
- Barbara Ukropcová, Prof. MD PhD, Study chair, Biomedical Research Center Slovak Acad SciJozef Ukropec, PhD, DSc, Principal investigator, Biomedical Research Center Slovak Acad Sci
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954298
- Sponsor's protocol ID
- 09I03-03-V04-00555
- Acronym
- COPMose
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and SAP will be available upon study completion, and primary and secondary outcomes (clinical study report) will be shared after publishing the results in a scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Dysregulation as the Underlying Principle of Integrated Pathophysiology of Obesity-associated Chronic Diseases: Molecular Landscape of Complex Lifestyle Modification
- ClinicalTrials.gov ID
- NCT06954298
- Acronym / sponsor ID
- COPMose / 09I03-03-V04-00555
- Conditions
- Obesity Prevention, Obesity, Metabolic Disease
- Keywords
- lifestyle intervention, exerkines, metabolic flexibility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Slovak Academy of SciencesOther government
- Collaborators
- Medical University of Vienna
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lifestyle intervention | Experimental | Behavioral: supervised lifestyle modification |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supervised lifestyle modificationSupervised lifestyle intervention will consist of regular exercise (3x a week), nutritional counselling (weekly), cognitive bahavioural therapy (monthly). | Behavioural | lifestyle intervention |
Primary outcome
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)
3 secondary outcomes
cardiopulmonary fitness (VO2max)
Time frame: 24 months
Index of insulin resistance (oGTT)
Time frame: 24 months
abdominal adiposity and abdominal adipose tissue distribution (subcutaneous / visceral)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Yes. Study protocol and SAP will be available upon study completion, and primary and secondary outcomes (clinical study report) will be shared after publishing the results in a scientific journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Ukropcová, Prof. MD PhD study chair
Biomedical Research Center Slovak Acad Sci
Jozef Ukropec, PhD, DSc principal investigator
Biomedical Research Center Slovak Acad Sci
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supervised lifestyle modification in people with Obesity Prevention and Obesity, run by Slovak Academy of Sciences at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic flexibility in response to submaximal exercise and nutritional challenge (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.