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Molecular Landscape of Complex Lifestyle Modification

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06954298
Acronym
COPMose
Enrollment
50
Registered
2025-05-01
Start date
2024-12-15
Completion date
2026-06-30
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Disease, Obesity, Obesity Prevention

Keywords

lifestyle intervention, exerkines, metabolic flexibility

Brief 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.

Interventions

BEHAVIORALsupervised lifestyle modification

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

Sponsors

Medical University Vienna
CollaboratorUNKNOWN
Slovak Academy of Sciences
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

BMI 30-45 kg.m-2 -

Exclusion criteria

smoking, cancer, \-

Design outcomes

Primary

MeasureTime frameDescription
Metabolic flexibility in response to submaximal exercise and nutritional challenge24 monthsMetabolic 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

MeasureTime frameDescription
cardiopulmonary fitness (VO2max)24 monthsCardiopulmonary fitness will be measured by bicycle spiro-ergometry
Index of insulin resistance (oGTT)24 monthsIndex of insulin resistance will be calculated from the results of the frequently sampled oral glucose tolerance test oGTT.
abdominal adiposity and abdominal adipose tissue distribution (subcutaneous / visceral)24 monthsabdominal adiposity will be assessed by quadrupedal biopimpedance, and adipose tissue distribution by magnetic resonance imagining

Countries

Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026