ObesityNCT05604196
Biomarkers of Metabolic Obesity.
An observational study of Obesity, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
The main aims of the work: Analysis of the concentration of selected pro-inflammatory parameters in blood serum and saliva of people with different distribution of subcutaneous and visceral adipose tissue. Analysis of metabolic obesity biomarkers in saliva and blood serum. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 119 participants
- Where
- 1 sitePoland
- Study dates
- 8 Jan 2020to 31 May 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 200 people volunteered for the study. The participants came from the Podlaskie Voivodeship, Poland. The first visit took place in the Department of Dietetics and Clinical Nutrition at the Medical University of Bialystok. Based on the inclusion and exclusion criteria the observational study was conducted among 119 people (79 women and 41 men).
Who may be able to join
- women and men aged 20-55
- primary obesity
- certificate from the dentist confirming the absence of periodontitis and inflammation in the oral cavity.
Who cannot join
- secondary obesity,
- type I and II diabetes,
- exacerbated coronary artery disease,
- endocrine disorders,
- eating disorders,
- pregnancy and lactation period,
Show all 9Show fewer
- use of hormonal contraception or hormone replacement therapy, steroid therapy, antiretroviral therapy,
- surgical or pharmacological history obesity treatment,
- pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Searching for Biomarkers of Metabolic Obesity.
The main aims of the work: Analysis of the concentration of selected pro-inflammatory parameters in blood serum and saliva of people with different distribution of subcutaneous and visceral adipose tissue. Analysis of metabolic obesity biomarkers in saliva and blood serum. Evaluation of new diagnostic methods for the early determination of the risk of metabolic obesity and its complications.
Based on the inclusion and exclusion criteria the observational study was conducted among 119 people (79 women and 41 men). Study group included 79 people (48 women and 31 men with obesity), and control group included 41 people (31 women and 10 men with normal body weight).
The study consisted of three visits. The first included qualification for the study, body composition measurements, ankle-brachial index test and completing the questionnaires and 3-day nutrition diaries. At the second visit blood was collected to conduct the morphological test. At the third visit saliva was collected to determine the proinflammatory cytokine and adipokine concentration.
Read the detailed description
The main aims of the work:
- Analysis of the concentration of selected pro-inflammatory parameters in blood serum and saliva of people with different distribution of subcutaneous and visceral adipose tissue.
- Analysis of metabolic obesity biomarkers in saliva and blood serum.
- Evaluation of new diagnostic methods for the early determination of the risk of metabolic obesity and its complications.
The study protocol was approved by the Bioethics Committee of the Medical University, no. R-I-002/647/2019 and APK.002.39.2021. All participants gave informed written consent to participate in the study before its commencement. The study began in January 2020 and ended in May 2022.
The research was carried out at the Department of Dietetics and Clinical Nutrition (Faculty of Health Sciences of the Medical University of Bialystok), Biochemical Diagnostics Department (University Clinical Hospital in Bialystok), as well as at the Department of Biotechnology (Faculty of Pharmacy with the Division of Laboratory Medicine of the Medical University of Bialystok).
The first visit took place in the Department of Dietetics and Clinical Nutrition at the Medical University of Bialystok. It included qualification for the study based on the inclusion and exclusion criteria, discussion of the purpose of the study and signing the written consent for the study by the participants, as well as information about the protection of their personal data and full anonymity. 200 people volunteered for the study. Based on the inclusion and exclusion criteria the observational study was conducted among 119 people (79 women and 41 men). Each participant received an individual code (e.g. A01, A02, B01, B02 etc.), which was used to identify the participants in further stages of the study.
All participants completed: The World Health Organization Quality of Life (WHOQOL- BREF) survey, International Physical Activity Questionnaire - IPAQ, Beliefs and Eating Habits Questionnaire created by Behavioral Conditions of Nutrition Team, Committee of Human Nutrition Science, Polish Academy of Science, and 3-day Nutrition Diary (participants described meals consumed for the next three days, including two working days and one day off).
The participants of the study had measurements of anthropometric parameters (body weight, height, waist and hip circumference) and the BMI (Body Mass Index) was calculated. On its basis the participants were divided into the study and control group. Moreover, the WHR ratio (Waist to Hip Ratio), WHtR ratio (Waist to Height Ratio) and RFM ratio (Relative Fat Mass) were calculated.
In order to determine the body composition of the study participants, an electrical bioimpedance body composition analysis was carried out using the devices: BioScan 920-2 (Great Britain, Essex) and InBody 270 (South Korea, Seoul). The examination was performed in the morning, fasting, without any intense physical exertion.
An ankle-brachial index test (MESI, Cracow, Poland) compares the blood pressure measured at the ankle with the blood pressure measured at the arm was also used in the study. This analysis was performed to assess the risk of lower limb atherosclerosis. Moreover blood pressure and resting heart rate using an electric sphygmomanometer was measured for all the study participants.
The second visit took place at the Biochemical Diagnostics Department (University Clinical Hospital in Bialystok). 10 ml of venous blood were collected from all participants in the study. Oral glucose tolerance test (OGTT) was performed, and on its basis, the concentration of glucose and insulin was determined (fasting, and after 60 and 120 minutes of the test). Concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, C-reactive protein, glucose, insulin, serum urea, serum creatinine, serum uric acid, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) was assessed on ALINITY ci, Abbott.
Blood samples were taken patients and frozen at -80 °C. Serum levels of total adiponectin (Quantikine ELISA Human Total Adiponectin/Acrp30 Immunoassay, R\&D Systems, Abingdon, UK), resistin (Quantikine ELISA Human Resistin Immunoassay, R\&D Systems, Abingdon, UK), IL-6 (Quantikine ELISA Human IL-6 Immunoassay, R\&D Systems, Abingdon, UK), TNFα (Quantikine ELISA Human TNFα Immunoassay, R\&D Systems, Abingdon, UK), IL-1β (Quantikine ELISA Human IL-1β/IL-1F2 Immunoassay, R\&D Systems, Abingdon, UK), IL-23 (Quantikine ELISA Human IL-23 Immunoassay, R\&D Systems, Abingdon, UK), MMP-9 (Quantikine ELISA Human MMP-9 Immunoassay, R\&D Systems, Abingdon, UK) and total MMP-2 (Quantikine ELISA Total MMP-2 Immunoassay, R\&D Systems, Abingdon, UK) were assessed with the enzyme-linked immunosorbent assay (ELISA) according to the manufactures' instructions.
The third visit took place at the Department of Biotechnology (Faculty of Pharmacy with the Division of Laboratory Medicine of the Medical University of Bialystok).
Saliva was collected using a standard method. Samples from the subjects were collected between 9:00 and 11:00 a.m. All subjects abstained from eating and drinking for 2 h. The subjects rinsed their mouths with deionized water and were sitting in a comfortable position with their eyes open and head titled slightly forward. Unstimulated whole saliva was collected for 10 min by spitting described by Navazesh. Saliva samples were homogenized and clarified by centrifugation at 1200 RPMI for 15 min at 4°C. The aliquots of clarified supernatants were stored at -70 °C for the ELISA measurements.
Highly sensitive assay kits (R\&D Systems, Minneapolis, USA) were used to determine the concentrations of IL-6, IL-1β, IL-23, resistin, MMP-9, MMP-2 and TNF-α in the salivary samples from the study participants. The tests were carried out according to the manufacturer's protocols. The microtiter plate provided in kits was pre-coated with monoclonal antibody specific for analyzed protein. Standards and samples were added to the appropriate microtiter plate wells. After the incubation at room temperature, enzyme-linked polyclonal antibody was added. Then, the microplate wells were aspirated and washed four times. Next, a substrate solution was added to each well. The enzyme-substrate reaction was terminated by the addition of a stop solution and the color change was measured spectrophotometrically at 450 nm ±2 nm. The antigen concentration in the samples was determined by comparing the O.D. to the standard curve. The antigen concentration in the samples was determined by comparing the O.D. to the standard curve.
- Conditions
- Obesity
- Keywords
- obesity, saliva, blood serum, BMI, proinflammatory cytokines, proinflammatory adipokines, IL-6, IL-23, IL-1beta, resistin, TNF-alpha, MMP-2, MMP-9
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STUDY GROUP | Study group included 79 people (48 women and 31 men), with BMI = 30.0-39.9 kg / m2) and excessive total body fat percent (TBF%) content (>30% TBF women and >25% TBF men). | |
| CONTROL GROUP | Control group included 41 people (31 women and 10 men), with BMI = 18.5-24.9 kg / m2) and normal total body fat percent (TBF%) content (20-30% TBF women and 15-20% TBF men). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the concentration of selected pro-inflammatory cytokines and adipokines in the saliva of patients with normal and excess body weight (obesity).
Analysis of the concentration in saliva of MMP-9, MMP-2, IL-6, TNF-α, resistin, IL-1β, IL-23 in patients with normal and excess body weight (obesity).
Measured: 24 months (analyzes were performed throughout the study period).
Analysis of the concentration of selected pro-inflammatory cytokines and adipokines in the blood serum of patients with normal and excess body weight (obesity).
Analysis of the concentration in saliva of adiponectin, IL-6,TNF-α, MMP-9, MMP-2, resistin, IL-1β, IL-23 in patients with normal and excess body weight (obesity).
Measured: 24 months (analyzes were performed throughout the study period).
Analysis of body composition of people with normal and excess body weight (obesity).
In order to determine the body composition of the study participants, an electrical bioimpedance body composition analysis was carried out using the InBody 270 (South Korea, Seoul) device, which enabled the assessment of the following parameters: total body fat percentage, total lean body mass percentage, total body fat mass, total skeletal muscle mass, total body water (L), extracellular (L) and intracellular (L) water.
Measured: 24 months (analyzes were performed throughout the study period).
Analysis of body composition and adipose tissue redistribution of people with normal and excess body weight (obesity).
In order to determine the body composition of the study participants an electrical bioimpedance body composition analysis was carried out using the device: BioScan 920-2 (Great Britain, Essex), which enabled the assessment of the following parameters: total body fat percentage, total lean body mass percentage, total body fat mass, total skeletal muscle mass, total body water (L), extracellular (L) and intracellular (L) water. Also, the area of adipose tissue in the abdominal cross-section was determined: visceral (VAT- Visceral Adipose Tissue) and subcutaneous (SAT- Subcutaneous Adipose Tissue), and visceral to subcutaneous fat ratio (VAT / SAT ratio).
Measured: 24 months (analyzes were performed throughout the study period).
Analysis of differences in the eating habits of people with normal and excessive body weight (obesity).
All participants completed "Beliefs and Eating Habits Questionnaire" created by Behavioral Conditions of Nutrition Team Committee of Human Nutrition Science, Polish Academy of Science.
Measured: 24 months (analyzes were performed throughout the study period).
Analysis of differences in the diet of people with normal and excessive body weight (obesity).
All participants completed 3-day Nutrition Diary.
Measured: 24 months (analyzes were performed throughout the study period).
Analysis of differences in physical activity of people with normal and excessive body weight (obesity).
All participants completed "International Physical Activity Questionnaire - IPAQ".
Measured: 24 months (analyzes were performed throughout the study period).
Analysis of differences in quality of life of people with normal and excessive body weight (obesity).
All participants completed The World Health Organization Quality of Life (WHOQOL- BREF) survey.
Measured: 24 months (analyzes were performed throughout the study period).
Risk assessment of lower limb atherosclerosis.
An ankle-brachial index test compares the blood pressure measured at the ankle with the blood pressure measured at the arm was used in the study.
Measured: 24 months (analyzes were performed throughout the study period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start8 Jan 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucyna Ostrowska, Professor, Principal investigator, Department of Dietetics and Clinical Nutrition Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604196
- Sponsor's protocol ID
- SUB/3/DN/20/001/3316
- Other IDs
- SUB/3/DN/21/001/3316
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang CZ, Cheng XQ, Li JY, Zhang P, Yi P, Xu X, Zhou XD. Saliva in the diagnosis of diseases. Int J Oral Sci. 2016 Sep 29;8(3):133-7. doi: 10.1038/ijos.2016.38.
PubMed 27585820Duffles LF, Hermont AP, Abreu LG, Pordeus IA, Silva TA. Association between obesity and adipokines levels in saliva and gingival crevicular fluid: A systematic review and meta-analysis. J Evid Based Med. 2019 Nov;12(4):313-324. doi: 10.1111/jebm.12363. Epub 2019 Sep 4.
PubMed 31482694Zysk B, Ostrowska L, Smarkusz-Zarzecka J. Salivary Adipokine and Cytokine Levels as Potential Markers for the Development of Obesity and Metabolic Disorders. Int J Mol Sci. 2021 Oct 28;22(21):11703. doi: 10.3390/ijms222111703.
PubMed 34769133Kunz HE, Hart CR, Gries KJ, Parvizi M, Laurenti M, Dalla Man C, Moore N, Zhang X, Ryan Z, Polley EC, Jensen MD, Vella A, Lanza IR. Adipose tissue macrophage populations and inflammation are associated with systemic inflammation and insulin resistance in obesity. Am J Physiol Endocrinol Metab. 2021 Jul 1;321(1):E105-E121. doi: 10.1152/ajpendo.00070.2021. Epub 2021 May 17.
PubMed 33998291Ostrowska L, Gornowicz A, Pietraszewska B, Bielawski K, Bielawska A. Which salivary components can differentiate metabolic obesity? PLoS One. 2020 Jun 29;15(6):e0235358. doi: 10.1371/journal.pone.0235358. eCollection 2020.
PubMed 32598403
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Searching for Biomarkers of Metabolic Obesity.
- ClinicalTrials.gov ID
- NCT05604196
- Acronym / sponsor ID
- SUB/3/DN/20/001/3316
- Conditions
- Obesity
- Keywords
- obesity, saliva, blood serum, BMI, proinflammatory cytokines, proinflammatory adipokines, IL-6, IL-23
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 Nov 2022 (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.
The main aims of the work: Analysis of the concentration of selected pro-inflammatory parameters in blood serum and saliva of people with different distribution of subcutaneous and visceral adipose tissue. Analysis of metabolic obesity biomarkers in saliva and blood serum. Evaluation of new diagnostic methods for the early determination of the risk of metabolic obesity and its complications.
Based on the inclusion and exclusion criteria the observational study was conducted among 119 people (79 women and 41 men). Study group included 79 people (48 women and 31 men with obesity), and control group included 41 people (31 women and 10 men with normal body weight).
The study consisted of three visits. The first included qualification for the study, body composition measurements, ankle-brachial index test and completing the questionnaires and 3-day nutrition diaries. At the second visit blood was collected to conduct the morphological test. At the third visit saliva was collected to determine the proinflammatory cytokine and adipokine concentration.
Detailed description
The main aims of the work:
- Analysis of the concentration of selected pro-inflammatory parameters in blood serum and saliva of people with different distribution of subcutaneous and visceral adipose tissue.
- Analysis of metabolic obesity biomarkers in saliva and blood serum.
- Evaluation of new diagnostic methods for the early determination of the risk of metabolic obesity and its complications.
The study protocol was approved by the Bioethics Committee of the Medical University, no. R-I-002/647/2019 and APK.002.39.2021. All participants gave informed written consent to participate in the study before its commencement. The study began in January 2020 and ended in May 2022.
The research was carried out at the Department of Dietetics and Clinical Nutrition (Faculty of Health Sciences of the Medical University of Bialystok), Biochemical Diagnostics Department (University Clinical Hospital in Bialystok), as well as at the Department of Biotechnology (Faculty of Pharmacy with the Division of Laboratory Medicine of the Medical University of Bialystok).
The first visit took place in the Department of Dietetics and Clinical Nutrition at the Medical University of Bialystok. It included qualification for the study based on the inclusion and exclusion criteria, discussion of the purpose of the study and signing the written consent for the study by the participants, as well as information about the protection of their personal data and full anonymity. 200 people volunteered for the study. Based on the inclusion and exclusion criteria the observational study was conducted among 119 people (79 women and 41 men). Each participant received an individual code (e.g. A01, A02, B01, B02 etc.), which was used to identify the participants in further stages of the study.
All participants completed: The World Health Organization Quality of Life (WHOQOL- BREF) survey, International Physical Activity Questionnaire - IPAQ, Beliefs and Eating Habits Questionnaire created by Behavioral Conditions of Nutrition Team, Committee of Human Nutrition Science, Polish Academy of Science, and 3-day Nutrition Diary (participants described meals consumed for the next three days, including two working days and one day off).
The participants of the study had measurements of anthropometric parameters (body weight, height, waist and hip circumference) and the BMI (Body Mass Index) was calculated. On its basis the participants were divided into the study and control group. Moreover, the WHR ratio (Waist to Hip Ratio), WHtR ratio (Waist to Height Ratio) and RFM ratio (Relative Fat Mass) were calculated.
In order to determine the body composition of the study participants, an electrical bioimpedance body composition analysis was carried out using the devices: BioScan 920-2 (Great Britain, Essex) and InBody 270 (South Korea, Seoul). The examination was performed in the morning, fasting, without any intense physical exertion.
An ankle-brachial index test (MESI, Cracow, Poland) compares the blood pressure measured at the ankle with the blood pressure measured at the arm was also used in the study. This analysis was performed to assess the risk of lower limb atherosclerosis. Moreover blood pressure and resting heart rate using an electric sphygmomanometer was measured for all the study participants.
The second visit took place at the Biochemical Diagnostics Department (University Clinical Hospital in Bialystok). 10 ml of venous blood were collected from all participants in the study. Oral glucose tolerance test (OGTT) was performed, and on its basis, the concentration of glucose and insulin was determined (fasting, and after 60 and 120 minutes of the test). Concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, C-reactive protein, glucose, insulin, serum urea, serum creatinine, serum uric acid, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) was assessed on ALINITY ci, Abbott.
Blood samples were taken patients and frozen at -80 °C. Serum levels of total adiponectin (Quantikine ELISA Human Total Adiponectin/Acrp30 Immunoassay, R\&D Systems, Abingdon, UK), resistin (Quantikine ELISA Human Resistin Immunoassay, R\&D Systems, Abingdon, UK), IL-6 (Quantikine ELISA Human IL-6 Immunoassay, R\&D Systems, Abingdon, UK), TNFα (Quantikine ELISA Human TNFα Immunoassay, R\&D Systems, Abingdon, UK), IL-1β (Quantikine ELISA Human IL-1β/IL-1F2 Immunoassay, R\&D Systems, Abingdon, UK), IL-23 (Quantikine ELISA Human IL-23 Immunoassay, R\&D Systems, Abingdon, UK), MMP-9 (Quantikine ELISA Human MMP-9 Immunoassay, R\&D Systems, Abingdon, UK) and total MMP-2 (Quantikine ELISA Total MMP-2 Immunoassay, R\&D Systems, Abingdon, UK) were assessed with the enzyme-linked immunosorbent assay (ELISA) according to the manufactures' instructions.
The third visit took place at the Department of Biotechnology (Faculty of Pharmacy with the Division of Laboratory Medicine of the Medical University of Bialystok).
Saliva was collected using a standard method. Samples from the subjects were collected between 9:00 and 11:00 a.m. All subjects abstained from eating and drinking for 2 h. The subjects rinsed their mouths with deionized water and were sitting in a comfortable position with their eyes open and head titled slightly forward. Unstimulated whole saliva was collected for 10 min by spitting described by Navazesh. Saliva samples were homogenized and clarified by centrifugation at 1200 RPMI for 15 min at 4°C. The aliquots of clarified supernatants were stored at -70 °C for the ELISA measurements.
Highly sensitive assay kits (R\&D Systems, Minneapolis, USA) were used to determine the concentrations of IL-6, IL-1β, IL-23, resistin, MMP-9, MMP-2 and TNF-α in the salivary samples from the study participants. The tests were carried out according to the manufacturer's protocols. The microtiter plate provided in kits was pre-coated with monoclonal antibody specific for analyzed protein. Standards and samples were added to the appropriate microtiter plate wells. After the incubation at room temperature, enzyme-linked polyclonal antibody was added. Then, the microplate wells were aspirated and washed four times. Next, a substrate solution was added to each well. The enzyme-substrate reaction was terminated by the addition of a stop solution and the color change was measured spectrophotometrically at 450 nm ±2 nm. The antigen concentration in the samples was determined by comparing the O.D. to the standard curve. The antigen concentration in the samples was determined by comparing the O.D. to the standard curve.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STUDY GROUP | – | –Study group included 79 people (48 women and 31 men), with BMI = 30.0-39.9 kg / m2) and excessive total body fat percent (TBF%) content (>30% TBF women and >25% TBF men). |
| CONTROL GROUP | – | –Control group included 41 people (31 women and 10 men), with BMI = 18.5-24.9 kg / m2) and normal total body fat percent (TBF%) content (20-30% TBF women and 15-20% TBF men). |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 200 people volunteered for the study. The participants came from the Podlaskie Voivodeship, Poland. The first visit took place in the Department of Dietetics and Clinical Nutrition at the Medical University of Bialystok. Based on the inclusion and exclusion criteria the observational study was conducted among 119 people (79 women and 41 men).
Key inclusion criteria (3 listed)
- women and men aged 20-55
- primary obesity
- certificate from the dentist confirming the absence of periodontitis and inflammation in the oral cavity.
Key exclusion criteria (9 listed)
- secondary obesity,
- type I and II diabetes,
- exacerbated coronary artery disease,
- endocrine disorders,
- eating disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analysis of the concentration of selected pro-inflammatory cytokines and adipokines in the saliva of patients with normal and excess body weight (obesity).
Time frame: 24 months (analyzes were performed throughout the study period).
Analysis of the concentration in saliva of MMP-9, MMP-2, IL-6, TNF-α, resistin, IL-1β, IL-23 in patients with normal and excess body weight (obesity).
Analysis of the concentration of selected pro-inflammatory cytokines and adipokines in the blood serum of patients with normal and excess body weight (obesity).
Time frame: 24 months (analyzes were performed throughout the study period).
Analysis of the concentration in saliva of adiponectin, IL-6,TNF-α, MMP-9, MMP-2, resistin, IL-1β, IL-23 in patients with normal and excess body weight (obesity).
Analysis of body composition of people with normal and excess body weight (obesity).
Time frame: 24 months (analyzes were performed throughout the study period).
In order to determine the body composition of the study participants, an electrical bioimpedance body composition analysis was carried out using the InBody 270 (South Korea, Seoul) device, which enabled the assessment of the following parameters: total body fat percentage, total lean body mass percentage, total body fat mass, total skeletal muscle mass, total body water (L), extracellular (L) and intracellular (L) water.
Analysis of body composition and adipose tissue redistribution of people with normal and excess body weight (obesity).
Time frame: 24 months (analyzes were performed throughout the study period).
In order to determine the body composition of the study participants an electrical bioimpedance body composition analysis was carried out using the device: BioScan 920-2 (Great Britain, Essex), which enabled the assessment of the following parameters: total body fat percentage, total lean body mass percentage, total body fat mass, total skeletal muscle mass, total body water (L), extracellular (L) and intracellular (L) water. Also, the area of adipose tissue in the abdominal cross-section was determined: visceral (VAT- Visceral Adipose Tissue) and subcutaneous (SAT- Subcutaneous Adipose Tissue), and visceral to subcutaneous fat ratio (VAT / SAT ratio).
Analysis of differences in the eating habits of people with normal and excessive body weight (obesity).
Time frame: 24 months (analyzes were performed throughout the study period).
All participants completed "Beliefs and Eating Habits Questionnaire" created by Behavioral Conditions of Nutrition Team Committee of Human Nutrition Science, Polish Academy of Science.
Analysis of differences in the diet of people with normal and excessive body weight (obesity).
Time frame: 24 months (analyzes were performed throughout the study period).
All participants completed 3-day Nutrition Diary.
Analysis of differences in physical activity of people with normal and excessive body weight (obesity).
Time frame: 24 months (analyzes were performed throughout the study period).
All participants completed "International Physical Activity Questionnaire - IPAQ".
Analysis of differences in quality of life of people with normal and excessive body weight (obesity).
Time frame: 24 months (analyzes were performed throughout the study period).
All participants completed The World Health Organization Quality of Life (WHOQOL- BREF) survey.
Risk assessment of lower limb atherosclerosis.
Time frame: 24 months (analyzes were performed throughout the study period).
An ankle-brachial index test compares the blood pressure measured at the ankle with the blood pressure measured at the arm was used in the study.
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 8 Nov 2022.
- Background: PubMed 27585820Zhang CZ, Cheng XQ, Li JY, Zhang P, Yi P, Xu X, Zhou XD. Saliva in the diagnosis of diseases. Int J Oral Sci. 2016 Sep 29;8(3):133-7. doi: 10.1038/ijos.2016.38.
- Background: PubMed 31482694Duffles LF, Hermont AP, Abreu LG, Pordeus IA, Silva TA. Association between obesity and adipokines levels in saliva and gingival crevicular fluid: A systematic review and meta-analysis. J Evid Based Med. 2019 Nov;12(4):313-324. doi: 10.1111/jebm.12363. Epub 2019 Sep 4.
- Background: PubMed 34769133Zysk B, Ostrowska L, Smarkusz-Zarzecka J. Salivary Adipokine and Cytokine Levels as Potential Markers for the Development of Obesity and Metabolic Disorders. Int J Mol Sci. 2021 Oct 28;22(21):11703. doi: 10.3390/ijms222111703.
- Background: PubMed 33998291Kunz HE, Hart CR, Gries KJ, Parvizi M, Laurenti M, Dalla Man C, Moore N, Zhang X, Ryan Z, Polley EC, Jensen MD, Vella A, Lanza IR. Adipose tissue macrophage populations and inflammation are associated with systemic inflammation and insulin resistance in obesity. Am J Physiol Endocrinol Metab. 2021 Jul 1;321(1):E105-E121. doi: 10.1152/ajpendo.00070.2021. Epub 2021 May 17.
- Background: PubMed 32598403Ostrowska L, Gornowicz A, Pietraszewska B, Bielawski K, Bielawska A. Which salivary components can differentiate metabolic obesity? PLoS One. 2020 Jun 29;15(6):e0235358. doi: 10.1371/journal.pone.0235358. eCollection 2020.
- World Health Assembly: Follow-up to the Political Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases. (Paper WHA66.10) 2013, 1-55.Link provided by the sponsor.
- World Obesity Federation: Global trends in obesity. \[in:\] Obesity: missing the 2025 global targets. Trends, Costs and Country Reports 2020, 16-33.Link provided by the sponsor.
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Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Lucyna Ostrowska, Professor principal investigator
Department of Dietetics and Clinical Nutrition Medical University of Bialystok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Medical University of Bialystok at 1 site 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 3 inclusion and 9 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Analysis of the concentration of selected pro-inflammatory cytokines and adipokines in the saliva of patients with normal and excess body weight (obesity). (time frame: 24 months (analyzes were performed throughout the study period).). The study lists 9 primary outcomes in all. 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 NCT05604196, which also lists 5 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 8 Nov 2022.