Body Weight Reduction and Metabolic/Biochemical Parameters in Overweight or Obesity

NCT07645105 | Completed

• 7 other identifiers: KNW/0022/KB1/19/I/16Secondary ID: KNW-1-016/N/7/2Secondary ID: KNW-1/109/K/8/ZSecondary ID: KNW-1/171/K/9/OSecondary ID: PCN-1-049/K/0/OSecondary ID: PCN-1-018/K/1/OSecondary ID: PCN-1-132/K/2/O
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

This was a single-center prospective observational cohort study conducted in Poland in the context of routine metabolic outpatient care. The study assessed selected metabolic, biochemical, oxidative-stress, inflammatory, and body-composition parameters in individuals with overweight or obesity undergoing standard lifestyle-based body weight reduction management. Participants with BMI \> 25 kg/m² were followed before and after body weight reduction, while individuals with normal body weight served as a comparison group. The weight reduction management included individualized dietary recommendations, physical-activity guidance, health education, regular follow-up visits, fasting blood sampling, and body-composition assessment. The aim of the study was to evaluate whether body weight reduction is associated with changes in metabolic and biochemical parameters, with particular attention to glucose and lipid metabolism, oxidative stress, inflammatory markers, adipokines, cytokines, and body-composition changes.

Conditions

Overweight , Obesity; Abdominal Obesity-Metabolic Syndrome

Keywords

body weight reduction; overweight; obesity; abdominal obesity; metabolic syndrome; body composition; glucose metabolism; lipid metabolism; oxidative stress; inflammatory markers; adipokines; cytokines

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  Change in body weight from baseline to follow-up after routine lifestyle-based body weight reduction management.

  Baseline and after body weight reduction, up to approximately 6 months

Secondary Outcomes (5)

• Change in Body Fat Mass

  Baseline and after body weight reduction, up to approximately 6 months

• Change in Glucose concentration in mg/dl.

  Baseline and after body weight reduction, up to approximately 6 months

• Change in total-cholesterol concentration in mg/dl.

  Baseline and after body weight reduction, up to approximately 6 months

• Change in malondialdehyde concentration in μmol/l.

  Baseline and after body weight reduction, up to approximately 6 months

• Change in serum IL-6 concentration in pg/ml.

  Baseline and after body weight reduction, up to approximately 6 months

Study Arms (1)

Individuals With Overweight or Obesity

Adults with BMI \> 25 kg/m² who were receiving routine lifestyle-based body weight reduction management in a metabolic outpatient clinic. Participants were prospectively observed and assessed before and after body weight reduction. Assessments included clinical and dietary questionnaires, anthropometric measurements, body-composition analysis, fasting blood sampling, and biochemical, metabolic, oxidative-stress, inflammatory, adipokine, and cytokine measurements.

Behavioral: Routine Lifestyle-Based Weight Reduction Management

Interventions

Routine Lifestyle-Based Weight Reduction Management BEHAVIORAL

Standard lifestyle-based body weight reduction management received as part of routine metabolic outpatient care. It included individualized dietary recommendations, physical-activity guidance, health education, and regular follow-up visits. Participants were not assigned to this management as part of the study; the study prospectively observed patients receiving routine care and assessed metabolic, biochemical, inflammatory, oxidative-stress, adipokine, cytokine, and body-composition parameters before and after body weight reduction.

Individuals With Overweight or Obesity

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with overweight or obesity who received routine lifestyle-based body weight reduction management in a metabolic outpatient clinic in Miasteczko Śląskie, Poland, and who provided written informed consent for participation in the study.

You may qualify if:

• Adults aged 18-85 years
• BMI \> 25 kg/m²
• Overweight or obesity diagnosed on the basis of medical examination and body-composition assessment
• Participation in routine lifestyle-based body weight reduction management in a metabolic outpatient clinic
• Written informed consent to participate in the study

You may not qualify if:

• Lack of informed consent
• Severe hepatic insufficiency
• Severe renal insufficiency
• Severe respiratory insufficiency
• Severe circulatory insufficiency
• Disturbances of consciousness
• Treatment-resistant depression
• Chronic alcohol abuse
• Pregnancy
• History of serious nervous system injury
• Implanted cardiac pacemaker
• Pharmacological treatment affecting glucose and/or lipid metabolism
• Incomplete follow-up or incomplete laboratory data

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (2)

Eko-Prof-Med Medical Center, Metabolic Outpatient Clinic

Miasteczko Śląskie, Silesian Voivodeship, 42-610, Poland

Location

Department of Biochemistry, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice

Zabrze, Silesian Voivodeship, 41-808, Poland

Location

Related Publications (5)

• Szlachta B, Birkova A, Cizmarova B, Glogowska-Gruszka A, Zalejska-Fiolka P, Dydon M, Zalejska-Fiolka J. Erythrocyte Oxidative Status in People with Obesity: Relation to Tissue Losses, Glucose Levels, and Weight Reduction. Antioxidants (Basel). 2024 Aug 7;13(8):960. doi: 10.3390/antiox13080960.

  PMID: 39199206 RESULT

• Szlachta B, Birkova A, Wielkoszynski T, Gospodarczyk A, Hubkova B, Dydon M, Zalejska-Fiolka J. Serum Oxidative Status in People with Obesity: Relation to Tissue Losses, Glucose Levels, and Weight Reduction. Antioxidants (Basel). 2023 Oct 27;12(11):1923. doi: 10.3390/antiox12111923.

  PMID: 38001776 RESULT

• Zalejska-Fiolka J, Birkova A, Hubkova B, Wielkoszynski T, Cizmarova B, Szlachta B, Fiolka R, Blaszczyk U, Wylegala A, Kasperczyk S, Grzanka A, Marekova M, Toborek M. Successful correction of hyperglycemia is critical for weight loss and a decrease in cardiovascular risk in obese patients. J Nutr Biochem. 2022 Aug;106:109021. doi: 10.1016/j.jnutbio.2022.109021. Epub 2022 Apr 25.

  PMID: 35472434 RESULT

• Zalejska-Fiolka J, Birkova A, Wielkoszynski T, Hubkova B, Szlachta B, Fiolka R, Blaszczyk U, Kuzan A, Gamian A, Marekova M, Toborek M. Loss of Skeletal Muscle Mass and Intracellular Water as Undesired Outcomes of Weight Reduction in Obese Hyperglycemic Women: A Short-Term Longitudinal Study. Int J Environ Res Public Health. 2022 Jan 17;19(2):1001. doi: 10.3390/ijerph19021001.

  PMID: 35055821 RESULT

• Zalejska-Fiolka J, Hubkova B, Birkova A, Velika B, Puchalska B, Kasperczyk S, Blaszczyk U, Fiolka R, Bozek A, Maksym B, Marekova M, Birkner E. Prognostic Value of the Modified Atherogenic Index of Plasma during Body Mass Reduction in Polish Obese/Overweight People. Int J Environ Res Public Health. 2018 Dec 27;16(1):68. doi: 10.3390/ijerph16010068.

  PMID: 30591697 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting venous blood samples and serum/plasma aliquots retained for biochemical, metabolic, oxidative-stress, antioxidant-status, inflammatory, adipokine, cytokine, chemokine, growth-factor, and cardiovascular-risk marker analyses. No DNA samples were collected or retained for genetic analyses.

MeSH Terms

Conditions

Overweight; Obesity; Abdominal obesity metabolic syndrome; Obesity, Abdominal; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Sławomir Kasperczyk, Prof

  Medical University of Silesia in Katowice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 12, 2026
• Study Start: May 10, 2016
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)