Molecular Landscape of Complex Lifestyle Modification

Not Applicable

Active, not recruiting

• Conditions: Obesity Prevention; Obesity; Metabolic Disease

• Registration Number: NCT06954298
• Lead Sponsor: Slovak Academy of Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-15
• Study First Submitted: 2025-03-30
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

BMI 30-45 kg.m-2 -

Exclusion Criteria

smoking, cancer,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Metabolic flexibility in response to submaximal exercise and nutritional challenge	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 Outcome Measures

Name	Time	Method
cardiopulmonary fitness (VO2max)	24 months	Cardiopulmonary fitness will be measured by bicycle spiro-ergometry
Index of insulin resistance (oGTT)	24 months	Index 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 months	abdominal adiposity will be assessed by quadrupedal biopimpedance, and adipose tissue distribution by magnetic resonance imagining

Trial Locations

Locations (1)

Center for Obesity Management EASO, Biomedical Research Center SAS; 🇸🇰 Bratislava, Slovakia