Overweight , ObesityNCT07645105
Body Weight Reduction and Metabolic/Biochemical Parameters in Overweight or Obesity
An observational study of Overweight , Obesity and Abdominal Obesity-Metabolic Syndrome, run by Medical University of Silesia at 2 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Overweight , Obesity, Abdominal Obesity-Metabolic Syndrome
- What is being tested?
- Routine Lifestyle-Based Weight Reduction Management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 53 participants
- Where
- 2 sitesPoland
- Study dates
- 10 May 2016to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Lack of informed consent
- Severe hepatic insufficiency
- Severe renal insufficiency
- Severe respiratory insufficiency
- Severe circulatory insufficiency
- Disturbances of consciousness
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Eko-Prof-Med Medical Center, Metabolic Outpatient Clinic
Miasteczko Śląskie, Silesian Voivodeship, 42-610
Department of Biochemistry, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice
Zabrze, Silesian Voivodeship, 41-808
About this study
Official title: The Effect of Body Weight Reduction on Selected Metabolic and Biochemical Parameters in Individuals With Overweight or Obesity
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.
Read the detailed description
This was a single-center prospective observational cohort study conducted at the Medical University of Silesia in Katowice, Poland, and in a metabolic outpatient clinic in Miasteczko Śląskie, Poland. The study was designed to evaluate the effect of body weight reduction on selected metabolic, biochemical, oxidative-stress, inflammatory, and body-composition parameters in individuals with overweight or obesity.
The study was conducted in the context of routine metabolic outpatient care. Participants with overweight or obesity received standard lifestyle-based body weight reduction management, including individualized dietary recommendations, physical-activity guidance, health education, and regular follow-up visits. The investigators did not assign participants to an investigational medicinal product, medical device, dietary supplement, surgical procedure, pharmacological intervention, or experimental therapy. The study prospectively observed participants receiving routine lifestyle-based weight reduction management and assessed changes in clinical and laboratory parameters before and after body weight reduction.
The approved study protocol planned the inclusion of individuals with overweight or obesity and a normal-weight comparison group. Participants with BMI > 25 kg/m² were evaluated in relation to body weight reduction, while individuals with normal body weight served as a comparison group for selected baseline analyses. Patients with overweight or obesity were assessed by medical examination, dietary and clinical questionnaires, anthropometric measurements, body-composition analysis, and fasting blood sampling. Body-composition analysis included assessment of body weight, fat mass, fat-free mass, skeletal muscle mass, total body water, visceral fat, and related parameters. Blood samples were collected for biochemical analyses, including markers of glucose metabolism, lipid metabolism, oxidative stress, antioxidant status, inflammatory markers, adipokines, cytokines, chemokines, growth factors, and selected cardiovascular-risk parameters.
Participants with overweight or obesity were followed during standard body weight reduction management until clinically relevant weight reduction or achievement of optimal body weight. According to the original study documentation, assessments were planned before the start of weight reduction, after approximately 10% body weight reduction, and after approximately 20% body weight reduction or achievement of target body weight. Follow-up visits included body weight measurements, waist and hip circumference measurements, dietary counselling, education regarding caloric intake, and motivation to continue lifestyle modification.
The primary objective of the study was to assess whether body weight reduction in individuals with overweight or obesity is associated with changes in selected metabolic and biochemical parameters. Secondary objectives included evaluation of oxidative-stress and antioxidant-status parameters, glucose and lipid metabolism, inflammatory markers, adipokines, cytokines, and body-composition changes. The study also aimed to assess relationships between biochemical parameters and body-composition indices before and after body weight reduction.
The study was approved by the Bioethics Committee of the Medical University of Silesia in Katowice, Poland. All participants received information about the study and provided written informed consent before participation. This ClinicalTrials.gov record is submitted retrospectively to meet journal publication requirements and to provide transparent public information about the completed study.
- Being tested
- Routine Lifestyle-Based Weight Reduction Management
- Keywords
- body weight reduction, overweight, obesity, abdominal obesity, metabolic syndrome, body composition, glucose metabolism, lipid metabolism, oxidative stress, inflammatory markers, adipokines, cytokines
- Medical subject headings
- Overweight, Obesity, Abdominal obesity metabolic syndrome, Obesity, Abdominal, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Lifestyle-Based Weight Reduction ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Routine Lifestyle-Based Weight Reduction Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Change in body weight from baseline to follow-up after routine lifestyle-based body weight reduction management.
Measured: Baseline and after body weight reduction, up to approximately 6 months
Secondary outcomes (5)
Change in Body Fat Mass
Change in body fat mass assessed by bioelectrical impedance analysis and expressed in kilograms.
Measured: Baseline and after body weight reduction, up to approximately 6 months
Change in Glucose concentration in mg/dl.
Changes in fasting glucose.
Measured: Baseline and after body weight reduction, up to approximately 6 months
Change in total-cholesterol concentration in mg/dl.
Changes in total cholesterol concentration.
Measured: Baseline and after body weight reduction, up to approximately 6 months
Change in malondialdehyde concentration in μmol/l.
Change in blood malondialdehyde concentration, assessed as a marker of lipid peroxidation and oxidative stress, from baseline to follow-up after body weight reduction.
Measured: Baseline and after body weight reduction, up to approximately 6 months
Change in serum IL-6 concentration in pg/ml.
Change in serum interleukin-6 (IL-6) concentration from baseline to follow-up after body weight reduction. IL-6 was measured in serum samples as a marker of systemic low-grade inflammation and expressed in pg/ml.
Measured: Baseline and after body weight reduction, up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start10 May 2016
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sławomir Kasperczyk, Prof, Principal investigator, Medical University of Silesia in Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645105
- Sponsor's protocol ID
- KNW/0022/KB1/19/I/16
- Other IDs
- Secondary ID: KNW-1-016/N/7/2, Secondary ID: KNW-1/109/K/8/Z, Secondary ID: KNW-1/171/K/9/O, Secondary ID: PCN-1-049/K/0/O, Secondary ID: PCN-1-018/K/1/O, Secondary ID: PCN-1-132/K/2/O
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because of privacy and confidentiality restrictions, limitations of the original informed consent, and the retrospective registration of this completed study. De-identified aggregate data or non-identifiable datasets may be made available from the investigators upon reasonable request, subject to institutional approval and applicable data protection regulations.
Publications
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.
PubMed 39199206Szlachta 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.
PubMed 38001776Zalejska-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.
PubMed 35472434Zalejska-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.
PubMed 35055821Zalejska-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.
PubMed 30591697Dydon M, Birkova A, Dolibog P, Cizmarova B, Hubkova B, Czuba Z, Zalejska-Fiolka P, Dydon A, Kasperczyk S, Skrzep-Poloczek B, Zalejska-Fiolka J. Sex-Specific Cytokine Responses and Metabolic Adaptation to Weight Loss in Obesity with Insulin Resistance. Nutrients. 2026 Jun 18;18(12):1982. doi: 10.3390/nu18121982.
PubMed 42356368
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Weight Reduction on Selected Metabolic and Biochemical Parameters in Individuals With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07645105
- Acronym / sponsor ID
- KNW/0022/KB1/19/I/16
- Keywords
- body weight reduction, overweight, obesity, abdominal obesity, metabolic syndrome, body composition, glucose metabolism, lipid metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a single-center prospective observational cohort study conducted at the Medical University of Silesia in Katowice, Poland, and in a metabolic outpatient clinic in Miasteczko Śląskie, Poland. The study was designed to evaluate the effect of body weight reduction on selected metabolic, biochemical, oxidative-stress, inflammatory, and body-composition parameters in individuals with overweight or obesity.
The study was conducted in the context of routine metabolic outpatient care. Participants with overweight or obesity received standard lifestyle-based body weight reduction management, including individualized dietary recommendations, physical-activity guidance, health education, and regular follow-up visits. The investigators did not assign participants to an investigational medicinal product, medical device, dietary supplement, surgical procedure, pharmacological intervention, or experimental therapy. The study prospectively observed participants receiving routine lifestyle-based weight reduction management and assessed changes in clinical and laboratory parameters before and after body weight reduction.
The approved study protocol planned the inclusion of individuals with overweight or obesity and a normal-weight comparison group. Participants with BMI > 25 kg/m² were evaluated in relation to body weight reduction, while individuals with normal body weight served as a comparison group for selected baseline analyses. Patients with overweight or obesity were assessed by medical examination, dietary and clinical questionnaires, anthropometric measurements, body-composition analysis, and fasting blood sampling. Body-composition analysis included assessment of body weight, fat mass, fat-free mass, skeletal muscle mass, total body water, visceral fat, and related parameters. Blood samples were collected for biochemical analyses, including markers of glucose metabolism, lipid metabolism, oxidative stress, antioxidant status, inflammatory markers, adipokines, cytokines, chemokines, growth factors, and selected cardiovascular-risk parameters.
Participants with overweight or obesity were followed during standard body weight reduction management until clinically relevant weight reduction or achievement of optimal body weight. According to the original study documentation, assessments were planned before the start of weight reduction, after approximately 10% body weight reduction, and after approximately 20% body weight reduction or achievement of target body weight. Follow-up visits included body weight measurements, waist and hip circumference measurements, dietary counselling, education regarding caloric intake, and motivation to continue lifestyle modification.
The primary objective of the study was to assess whether body weight reduction in individuals with overweight or obesity is associated with changes in selected metabolic and biochemical parameters. Secondary objectives included evaluation of oxidative-stress and antioxidant-status parameters, glucose and lipid metabolism, inflammatory markers, adipokines, cytokines, and body-composition changes. The study also aimed to assess relationships between biochemical parameters and body-composition indices before and after body weight reduction.
The study was approved by the Bioethics Committee of the Medical University of Silesia in Katowice, Poland. All participants received information about the study and provided written informed consent before participation. This ClinicalTrials.gov record is submitted retrospectively to meet journal publication requirements and to provide transparent public information about the completed study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals With Overweight or Obesity | – | Behavioral: Routine Lifestyle-Based Weight Reduction ManagementAdults 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Lack of informed consent
- Severe hepatic insufficiency
- Severe renal insufficiency
- Severe respiratory insufficiency
- Severe circulatory insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Lifestyle-Based Weight Reduction ManagementStandard 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. | Behavioural | Individuals With Overweight or Obesity |
Primary outcome
Change in Body Weight
Time frame: Baseline and after body weight reduction, up to approximately 6 months
Change in body weight from baseline to follow-up after routine lifestyle-based body weight reduction management.
5 secondary outcomes
Change in Body Fat Mass
Time frame: Baseline and after body weight reduction, up to approximately 6 months
Change in Glucose concentration in mg/dl.
Time frame: Baseline and after body weight reduction, up to approximately 6 months
Change in total-cholesterol concentration in mg/dl.
Time frame: Baseline and after body weight reduction, up to approximately 6 months
Change in malondialdehyde concentration in μmol/l.
Time frame: Baseline and after body weight reduction, up to approximately 6 months
Change in serum IL-6 concentration in pg/ml.
Time frame: Baseline and after body weight reduction, up to approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 39199206Szlachta 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.
- Results publication: PubMed 38001776Szlachta 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.
- Results publication: PubMed 35472434Zalejska-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.
- Results publication: PubMed 35055821Zalejska-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.
- Results publication: PubMed 30591697Zalejska-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.
- Derived from this study: PubMed 42356368Dydon M, Birkova A, Dolibog P, Cizmarova B, Hubkova B, Czuba Z, Zalejska-Fiolka P, Dydon A, Kasperczyk S, Skrzep-Poloczek B, Zalejska-Fiolka J. Sex-Specific Cytokine Responses and Metabolic Adaptation to Weight Loss in Obesity with Insulin Resistance. Nutrients. 2026 Jun 18;18(12):1982. doi: 10.3390/nu18121982.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because of privacy and confidentiality restrictions, limitations of the original informed consent, and the retrospective registration of this completed study. De-identified aggregate data or non-identifiable datasets may be made available from the investigators upon reasonable request, subject to institutional approval and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sławomir Kasperczyk, Prof principal investigator
Medical University of Silesia in Katowice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight , Obesity and Abdominal Obesity-Metabolic Syndrome, run by Medical University of Silesia at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline and after body weight reduction, up to approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07645105, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.