Molecular Landscape of Complex Lifestyle Modification

NCT ID: NCT06954298

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Obesity Prevention Obesity Metabolic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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lifestyle intervention

Group Type EXPERIMENTAL

supervised lifestyle modification

Intervention Type BEHAVIORAL

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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supervised lifestyle modification

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Vienna

UNKNOWN

Sponsor Role collaborator

Slovak Academy of Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jozef Ukropec

PhD, DSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Ukropcová, Prof. MD PhD

Role: STUDY_CHAIR

Biomedical Research Center Slovak Acad Sci

Jozef Ukropec, PhD, DSc

Role: PRINCIPAL_INVESTIGATOR

Biomedical Research Center Slovak Acad Sci

Locations

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Center for Obesity Management EASO, Biomedical Research Center SAS

Bratislava, Bratislava Region, Slovakia

Site Status

Countries

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Slovakia

Other Identifiers

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09I03-03-V04-00555

Identifier Type: -

Identifier Source: org_study_id

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