ClinicalTrials.gg
Active, not recruitingNCT06954298COPMoseUpdated May 1, 2025

Molecular Landscape of Complex Lifestyle Modification

An interventional study of supervised lifestyle modification in Obesity Prevention, Obesity and Metabolic Disease, sponsored by Slovak Academy of Sciences. Active, not recruiting at 1 site in Slovakia. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-05-01.

Sponsored by Slovak Academy of Sciences · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
  • Registered 3 months after the study started (first participant enrolled Dec 2024, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 34 studies in Obesity with a site in Slovakia — 9 open to participants now, 17 under way, 14 of them phase 3. Obesity · Slovakia.

Planned enrollment
31st of 34
50 · median 632
Started
2024
with 1 other
No phase
6 of 34
1 open now
Primary completion
2025-12
later than 1 of 16 live
Registered
19th of 34
by date
Lead sponsor
5 of 34
Slovak Academy of Sciences

Among the 34 studies in Obesity with a site in Slovakia, this one is the 31st largest by planned enrollment, is one of 2 that started in 2024, is one of 6 with no phase, reaches primary completion later than 1 of the 16 other live ones, and was the 19th registered.

By phase

34 studies; the count open now beside each. This study's row is marked.

Phase 324 · 7 open
No phasethis study6 · 1 open
Phase 12 · 1 open
Phase 22 · 0 open

By the year they started

First in 2006; this study’s year is marked. 2 started in 2024.

Size and results

Median enrollment 632 across the 34 interventional studies. Of the 14 that completed or were terminated, 4 (29%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 34 studies in Obesity with a site in Slovakia, or all of them as a file.
02

Study 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.
03

Conditions studied

  • Obesity Prevention
  • Obesity
  • Metabolic Disease

Keywords

  • lifestyle intervention
  • exerkines
  • metabolic flexibility
04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: 30-45 kg.m-2 -

Exclusion Criteria: smoking, cancer,

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    lifestyle intervention

    Behavioral: supervised lifestyle modification

  • No intervention
    Control

Interventions

  • Behavioralsupervised lifestyle modification

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 24 months

Secondary outcomes

  1. cardiopulmonary fitness (VO2max)

    Cardiopulmonary fitness will be measured by bicycle spiro-ergometry

    Time frame: 24 months

  2. Index of insulin resistance (oGTT)

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

    Time frame: 24 months

  3. 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

    Time frame: 24 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: 06/2026 (start date) indefinitely (end date)

Access criteria: researchers with legitimate interest

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Dec 2025, 12 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 12 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2025
First posted
May 1, 2025
StartActual
Dec 15, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Jun 30, 2026
Last update
May 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06954298
Lead sponsor
Slovak Academy of Sciences
Collaborators
Medical University Vienna
Responsible party
Jozef Ukropec (PhD, DSc, Slovak Academy of Sciences) — Principal investigator
First posted
May 1, 2025
Start date
Dec 15, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
May 1, 2025

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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