Molecular Landscape of Complex Lifestyle Modification

NCT06954298 | Active Not Recruiting DMC

• 1 other identifier: 09I03-03-V04-00555
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity Prevention; Obesity; Metabolic Disease

Keywords

lifestyle intervention; exerkines; metabolic flexibility

Outcome Measures

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)

  24 months

Secondary Outcomes (3)

• cardiopulmonary fitness (VO2max)

  24 months

• Index of insulin resistance (oGTT)

  24 months

• abdominal adiposity and abdominal adipose tissue distribution (subcutaneous / visceral)

  24 months

Study Arms (2)

lifestyle intervention

EXPERIMENTAL

Behavioral: supervised lifestyle modification

Control

NO INTERVENTION

Interventions

supervised lifestyle modification BEHAVIORAL

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

lifestyle intervention

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Slovak Academy of Sciences: lead
• Medical University Vienna: collaborator

Study Sites (1)

Center for Obesity Management EASO, Biomedical Research Center SAS

Bratislava, Bratislava Region, 84505, Slovakia

Location

MeSH Terms

Conditions

Obesity; Metabolic Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barbara Ukropcová, Prof. MD PhD

  Biomedical Research Center Slovak Acad Sci

  STUDY CHAIR

• Jozef Ukropec, PhD, DSc

  Biomedical Research Center Slovak Acad Sci

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, DSc

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: May 1, 2025
• Study Start: December 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 06/2026 (start date) indefinitely (end date)
• Access Criteria: researchers with legitimate interest

Locations

SL (1)