Molecular Landscape of Complex Lifestyle Modification (COPMose)

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?

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 Overview

• Status: Active, not recruiting
• Conditions: Obesity; Metabolic Disease; Obesity Prevention
• Intervention / Treatment: Behavioral: supervised lifestyle modification

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovakia
  • Bratislava, Slovakia, 84505
    • Center for Obesity Management EASO, Biomedical Research Center SAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria: smoking, cancer,

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: lifestyle intervention	Behavioral: supervised lifestyle modification; Supervised lifestyle intervention will consist of regular exercise (3x a week), nutritional counselling (weekly), cognitive bahavioural therapy (monthly).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiopulmonary fitness (VO2max)	Cardiopulmonary fitness will be measured by bicycle spiro-ergometry	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.	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	24 months

Collaborators and Investigators

• Sponsor: Slovak Academy of Sciences
• Collaborators: Medical University Vienna
• Investigators: Study Chair: Barbara Ukropcová, Prof. MD PhD, Biomedical Research Center Slovak Acad Sci; Principal Investigator: Jozef Ukropec, PhD, DSc, Biomedical Research Center Slovak Acad Sci

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 30, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: lifestyle intervention; exerkines; metabolic flexibility
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Metabolic Diseases
• Other Study ID Numbers: 09I03-03-V04-00555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 06/2026 (start date) indefinitely (end date)
• IPD Sharing Access Criteria: researchers with legitimate interest
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No