Periodontal DiseasesNCT06250764
Asprosin, Adropin, Irisin Levels in Periodontitis
An observational study of Periodontal Diseases and Gingivitis, run by AYSAN LEKTEMUR ALPAN at 1 site in Turkey (Türkiye).
Trial summary
The recently discovered association of the hormones 'asprosin, adropin and irisin' with obesity and metabolic status, as well as the fact that periodontal diseases are affected by obesity and nutrition bilaterally, have led us to investigate the relationship between selected target markers and periodontal disease. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Gingivitis, Obesity
- What is being tested?
- Clinical periodontal measuremenets and ELISA test from gingival crevicular fluid (GCF)
- Type of treatment
- Injection or infusion
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2020to 23 Feb 2022
- How long will I take part?
- 3 Days
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All patients admitted to the periodontology clinic between the study dates
Who may be able to join
- All patients but exclusion criteria
Who cannot join
- Patients with cardiovascular disease, liver and kidney disease, metabolic disorders, diabetes, asthma, thyroid dysfunction, who used antibiotics or anti-inflammatory drugs within the last three months, who received periodontal treatment within the last six months, obese patients with body mass index (BMI) ≥ 30 kg/m2 according to the reference range determined by the World Health Organisation, and patients who refused to participate were excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adıyaman University Faculty of Dentistry
Adıyaman
About this study
Official title: Investigation the Relationship Between Periodontal Disease and 'Asprosin, Adropin, Irisin' Levels
The recently discovered association of the hormones 'asprosin, adropin and irisin' with obesity and metabolic status, as well as the fact that periodontal diseases are affected by obesity and nutrition bilaterally, have led us to investigate the relationship between selected target markers and periodontal disease. The primary aim and main objective of this study is to increase the knowledge and to direct future researches as a result of the lack of adequate research in the past and the very limited investigations with these hormones in dentistry and periodontology.
Our study was conducted on 122 patients who applied to Adıyaman University Faculty of Dentistry and were referred to the Department of Periodontology for routine periodontal controls. Participants' gender, age, height, weight, BMI, education level, tooth brushing and flossing habits as well as clinical parameters PI, GI, SCD, CAS and SDI were noted. Participants were divided into 4 groups as healthy, gingivitis, initial periodontitis and advanced periodontitis and grouped according to the current periodontal classification of 2017. DOS was collected from the groups for examination and 'asprosin, adropin and irisin' values in the samples were evaluated by ELISA test.
Read the detailed description
A total of 122 patients participated in the study. All patients participating in the trial received written and verbal information about the purpose and method of the study and signed consent. Patients with cardiovascular disease, liver and kidney disease, metabolic disorders, diabetes, asthma, thyroid dysfunction, who used antibiotics or anti-inflammatory drugs within the last three months, who received periodontal treatment within the last six months, obese patients with body mass index (BMI) ≥ 30 kg/m2 according to the reference range determined by the World Health Organization, and patients who refused to participate were excluded from the study. In order to calculate the BMI of the individuals included in the study, height-weight information, tooth brushing frequency in order to determine oral hygiene habits, and educational status were also recorded to determine economic levels. Age and gender were also noted. Individuals aged 25-60 years were divided into four groups according to their periodontal status.
The periodontal assessment was performed by a single trained examiner (S.D.). A graded periodontal probe (Williams, Hu-Friedy, Chicago, IL, USA) was used to measure probing depth (PD), which was determined as the depth from the gingival margin to the bottom of the gingival sulcus/periodontal pocket; clinical attachment loss (CAL) which was calculated as the distance from the cemento-enamel junction to the bottom of the periodontal pocket and dual recording (+/-) of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) in total except third molars. To assess the intra-examiner calibration, Cronbach's alpha was used and its value was 0.90 for PD and CAL measures. Alveolar bone loss (ABL) was determined in each participant by orthopantomography. The distance between the cemento-enamel junction and the bone crest was measured in both mesial and distal regions and its ratio to the root length was calculated to assess bone loss. The periodontal status of the patients was evaluated based on the Classification of Periodontal and Peri-Implant Diseases and Conditions from the 2017 World Workshop. Participants were classified into four distinct groups based on their periodontal conditions:
- Group 1: 30 periodontally healthy individuals;
- Group 2: 30 patients with gingivitis;
- Group 3: 32 patients with generalized stage I and stage II periodontitis;
- Group 4: 30 patients with generalized stage III and stage IV periodontitis. An individual to be considered to have periodontal health according to this definition, the percentage of sites with bleeding on probing should be no more than 10%, and the probing depth should be 3 mm or less. Patients with gingivitis had PD ≤3 mm, BOP in ≥30% of the probing sites, and no interproximal AL or radiographic bone loss. Stage I periodontitis was diagnosed with interdental attachment loss (AL) ranging between 1 and 2 mm at the site of greatest loss. Radiographic bone loss (BL) is limited to less than 15% and no tooth loss. Additionally, the maximum probing depth (PD) is equal to or less than 4 mm, which primarily involves horizontal bone loss. Stage II periodontitis was diagnosed with interdental attachment loss (AL) ranging between 3 and 4 mm at the site of greatest loss. Radiographic bone loss (BL) extends to a range of 15% to 33%; there is no tooth loss. The maximum probing depth (PD) is equal to or less than 5 mm, or primarily involves horizontal bone loss. Stage III periodontitis is diagnosed when interdental attachment loss (AL) is ≥ 5, radiographic bone loss (BL) extends to the mid-third of the root and beyond, and tooth loss may become evident ≤4 teeth. Either PD ≥ 6 mm or vertical BL ≥ 3 mm, or Class II/III furcation involvement, or moderate ridge defect. Stage IV periodontitis is diagnosed with interdental attachment loss (AL) of ≥ 5 mm at the site of greatest loss, with radiographic BL extending to the mid-third of the root and beyond. ≥5 tooth losses due to periodontitis are evident. In addition to Stage III, either masticatory dysfunction, secondary occlusal trauma (tooth mobility degree ≥ 2), severe ridge defect, bite collapse, or teeth drifting and flaring
- Conditions
- Periodontal Diseases, Gingivitis, Obesity
- Being tested
- Clinical periodontal measuremenets, ELISA test from gingival crevicular fluid (GCF)
- Keywords
- adropin, asprosin, irisin, periodontal disease, gingival crevicular fluid
- Medical subject headings
- Periodontal Diseases, Gingivitis, Obesity, Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical periodontal measuremenetsDiagnostic test
The periodontal assessment was performed by a single trained examiner (S.D.). A graded periodontal probe (Williams, Hu-Friedy, Chicago, IL, USA) was used to measure probing depth (PD) which was determined as the depth from the gingival margin to the bottom of the gingival sulcus/periodontal pocket, clinical attachment loss (CAL) which was calculated as the distance from the cemento-enamel junction to the bottom of the periodontal pocket and dual recording (+/-) of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) in total except third molars G
ELISA test from gingival crevicular fluid (GCF)Diagnostic test
GCF sampled from the buccal aspects of non-contiguous proximal regions in maxillary single-rooted teeth. In the periodontitis groups, fluid samples were taken from the two deepest pockets. In the gingivitis and periodontal healthy groups, fluid samples were obtained from areas with and without visible inflammation, respectively
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 (periodontally healthy ) | An individual to be considered to have periodontal health according to this definition, the percentage of sites with bleeding on probing should be no more than 10%, and the probing depth should be 3 mm or less Receives: Diagnostic Test: Clinical periodontal measuremenets; Diagnostic Test: ELISA test from gingival crevicular fluid (GCF) | |
| GROUP 2 (gingivitis) | Patients with gingivitis had PD ≤3 mm, BOP in ≥30% of the probing sites, and no interproximal AL or radiographic bone loss Receives: Diagnostic Test: Clinical periodontal measuremenets; Diagnostic Test: ELISA test from gingival crevicular fluid (GCF) | |
| GROUP 3(generalized stage I and stage II periodontitis) | Stage I periodontitis was diagnosed with interdental attachment loss (AL) ranging between 1 and 2 mm at the site of greatest loss. Radiographic bone loss (BL) is limited to less than 15% and no tooth loss. Additionally, the maximum probing depth (PD) is equal to or less than 4 mm or primarily involves horizontal bone loss. Stage II periodontitis was diagnosed with interdental attachment loss (AL) is ranging between 3 and 4 mm at the site of greatest loss. Radiographic bone loss (BL) extends to a range of 15% to 33%, there is no tooth loss. The maximum probing depth (PD) is equal to or less than 5 mm or primarily involves horizontal bone loss. Receives: Diagnostic Test: Clinical periodontal measuremenets; Diagnostic Test: ELISA test from gingival crevicular fluid (GCF) | |
| GROUP 4 (generalized stage III and stage IV periodontitis) | Stage III periodontitis is diagnosed with interdental attachment loss (AL) is ≥ 5, radiographic bone loss (BL) extends to mid-third of the root and beyond, tooth loss may become evident ≤4 teeth. Either PD ≥ 6 mm or vertical BL ≥ 3 mm, or Class II/III furcation involvement, or moderate ridge defect. Stage IV periodontitis is diagnosed with interdental attachment loss (AL) is ≥ 5 mm at the site of greatest loss, radiographic BL extending to mid-third of the root and beyond. ≥5 tooth loss due to periodontitis is evident. In addition to Stage III, either masticatory dysfunction, or secondary occlusal trauma (tooth mobility degree ≥ 2), or severe ridge defect, or bite collapse, or teeth drifting and flaring Receives: Diagnostic Test: Clinical periodontal measuremenets; Diagnostic Test: ELISA test from gingival crevicular fluid (GCF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of PD and adipokine values
correlation identification using SPSS between pocket depth and these adipokines in periodontitis patients
Measured: only baseline measurement the patients were seen once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start12 Feb 2020
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- 122 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- AYSAN LEKTEMUR ALPAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AYSAN LEKTEMUR ALPAN, Pamukkale University
- Investigators
- METİN ÇALIŞIR, PHD, Principal investigator, Adiyaman UniversitySevde DEMİRCİ, Study director, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250764
- Sponsor's protocol ID
- 2020/9-10
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loesche WJ, Grossman NS. Periodontal disease as a specific, albeit chronic, infection: diagnosis and treatment. Clin Microbiol Rev. 2001 Oct;14(4):727-52, table of contents. doi: 10.1128/CMR.14.4.727-752.2001.
PubMed 11585783Torumtay Cin G, Fenkci SM, Kilic ID, Aslan HS, Sevgican CI, Senol H. The effects of severe periodontitis on arterial stiffness using cardio-ankle vascular index in patients with type 2 diabetes. J Periodontal Res. 2024 Feb;59(1):74-83. doi: 10.1111/jre.13202. Epub 2023 Nov 1.
PubMed 37909328
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation the Relationship Between Periodontal Disease and 'Asprosin, Adropin, Irisin' Levels
- ClinicalTrials.gov ID
- NCT06250764
- Acronym / sponsor ID
- 2020/9-10
- Conditions
- Periodontal Diseases, Gingivitis, Obesity
- Keywords
- adropin, asprosin, irisin, periodontal disease, gingival crevicular fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- AYSAN LEKTEMUR ALPANUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 9 Feb 2024 (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 recently discovered association of the hormones 'asprosin, adropin and irisin' with obesity and metabolic status, as well as the fact that periodontal diseases are affected by obesity and nutrition bilaterally, have led us to investigate the relationship between selected target markers and periodontal disease. The primary aim and main objective of this study is to increase the knowledge and to direct future researches as a result of the lack of adequate research in the past and the very limited investigations with these hormones in dentistry and periodontology.
Our study was conducted on 122 patients who applied to Adıyaman University Faculty of Dentistry and were referred to the Department of Periodontology for routine periodontal controls. Participants' gender, age, height, weight, BMI, education level, tooth brushing and flossing habits as well as clinical parameters PI, GI, SCD, CAS and SDI were noted. Participants were divided into 4 groups as healthy, gingivitis, initial periodontitis and advanced periodontitis and grouped according to the current periodontal classification of 2017. DOS was collected from the groups for examination and 'asprosin, adropin and irisin' values in the samples were evaluated by ELISA test.
Detailed description
A total of 122 patients participated in the study. All patients participating in the trial received written and verbal information about the purpose and method of the study and signed consent. Patients with cardiovascular disease, liver and kidney disease, metabolic disorders, diabetes, asthma, thyroid dysfunction, who used antibiotics or anti-inflammatory drugs within the last three months, who received periodontal treatment within the last six months, obese patients with body mass index (BMI) ≥ 30 kg/m2 according to the reference range determined by the World Health Organization, and patients who refused to participate were excluded from the study. In order to calculate the BMI of the individuals included in the study, height-weight information, tooth brushing frequency in order to determine oral hygiene habits, and educational status were also recorded to determine economic levels. Age and gender were also noted. Individuals aged 25-60 years were divided into four groups according to their periodontal status.
The periodontal assessment was performed by a single trained examiner (S.D.). A graded periodontal probe (Williams, Hu-Friedy, Chicago, IL, USA) was used to measure probing depth (PD), which was determined as the depth from the gingival margin to the bottom of the gingival sulcus/periodontal pocket; clinical attachment loss (CAL) which was calculated as the distance from the cemento-enamel junction to the bottom of the periodontal pocket and dual recording (+/-) of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) in total except third molars. To assess the intra-examiner calibration, Cronbach's alpha was used and its value was 0.90 for PD and CAL measures. Alveolar bone loss (ABL) was determined in each participant by orthopantomography. The distance between the cemento-enamel junction and the bone crest was measured in both mesial and distal regions and its ratio to the root length was calculated to assess bone loss. The periodontal status of the patients was evaluated based on the Classification of Periodontal and Peri-Implant Diseases and Conditions from the 2017 World Workshop. Participants were classified into four distinct groups based on their periodontal conditions:
- Group 1: 30 periodontally healthy individuals;
- Group 2: 30 patients with gingivitis;
- Group 3: 32 patients with generalized stage I and stage II periodontitis;
- Group 4: 30 patients with generalized stage III and stage IV periodontitis. An individual to be considered to have periodontal health according to this definition, the percentage of sites with bleeding on probing should be no more than 10%, and the probing depth should be 3 mm or less. Patients with gingivitis had PD ≤3 mm, BOP in ≥30% of the probing sites, and no interproximal AL or radiographic bone loss. Stage I periodontitis was diagnosed with interdental attachment loss (AL) ranging between 1 and 2 mm at the site of greatest loss. Radiographic bone loss (BL) is limited to less than 15% and no tooth loss. Additionally, the maximum probing depth (PD) is equal to or less than 4 mm, which primarily involves horizontal bone loss. Stage II periodontitis was diagnosed with interdental attachment loss (AL) ranging between 3 and 4 mm at the site of greatest loss. Radiographic bone loss (BL) extends to a range of 15% to 33%; there is no tooth loss. The maximum probing depth (PD) is equal to or less than 5 mm, or primarily involves horizontal bone loss. Stage III periodontitis is diagnosed when interdental attachment loss (AL) is ≥ 5, radiographic bone loss (BL) extends to the mid-third of the root and beyond, and tooth loss may become evident ≤4 teeth. Either PD ≥ 6 mm or vertical BL ≥ 3 mm, or Class II/III furcation involvement, or moderate ridge defect. Stage IV periodontitis is diagnosed with interdental attachment loss (AL) of ≥ 5 mm at the site of greatest loss, with radiographic BL extending to the mid-third of the root and beyond. ≥5 tooth losses due to periodontitis are evident. In addition to Stage III, either masticatory dysfunction, secondary occlusal trauma (tooth mobility degree ≥ 2), severe ridge defect, bite collapse, or teeth drifting and flaring
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 (periodontally healthy ) | – | Diagnostic Test: Clinical periodontal measuremenets, Diagnostic Test: ELISA test from gingival crevicular fluid (GCF)An individual to be considered to have periodontal health according to this definition, the percentage of sites with bleeding on probing should be no more than 10%, and the probing depth should be 3 mm or less |
| GROUP 2 (gingivitis) | – | Diagnostic Test: Clinical periodontal measuremenets, Diagnostic Test: ELISA test from gingival crevicular fluid (GCF)Patients with gingivitis had PD ≤3 mm, BOP in ≥30% of the probing sites, and no interproximal AL or radiographic bone loss |
| GROUP 3(generalized stage I and stage II periodontitis) | – | Diagnostic Test: Clinical periodontal measuremenets, Diagnostic Test: ELISA test from gingival crevicular fluid (GCF)Stage I periodontitis was diagnosed with interdental attachment loss (AL) ranging between 1 and 2 mm at the site of greatest loss. Radiographic bone loss (BL) is limited to less than 15% and no tooth loss. Additionally, the maximum probing depth (PD) is equal to or less than 4 mm or primarily involves horizontal bone loss. Stage II periodontitis was diagnosed with interdental attachment loss (AL) is ranging between 3 and 4 mm at the site of greatest loss. Radiographic bone loss (BL) extends to a range of 15% to 33%, there is no tooth loss. The maximum probing depth (PD) is equal to or less than 5 mm or primarily involves horizontal bone loss. |
| GROUP 4 (generalized stage III and stage IV periodontitis) | – | Diagnostic Test: Clinical periodontal measuremenets, Diagnostic Test: ELISA test from gingival crevicular fluid (GCF)Stage III periodontitis is diagnosed with interdental attachment loss (AL) is ≥ 5, radiographic bone loss (BL) extends to mid-third of the root and beyond, tooth loss may become evident ≤4 teeth. Either PD ≥ 6 mm or vertical BL ≥ 3 mm, or Class II/III furcation involvement, or moderate ridge defect. Stage IV periodontitis is diagnosed with interdental attachment loss (AL) is ≥ 5 mm at the site of greatest loss, radiographic BL extending to mid-third of the root and beyond. ≥5 tooth loss due to periodontitis is evident. In addition to Stage III, either masticatory dysfunction, or secondary occlusal trauma (tooth mobility degree ≥ 2), or severe ridge defect, or bite collapse, or teeth drifting and flaring |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients admitted to the periodontology clinic between the study dates
Key inclusion criteria (1 listed)
- All patients but exclusion criteria
Key exclusion criteria (1 listed)
- Patients with cardiovascular disease, liver and kidney disease, metabolic disorders, diabetes, asthma, thyroid dysfunction, who used antibiotics or anti-inflammatory drugs within the last three months, who received periodontal treatment within the last six months, obese patients with body mass index (BMI) ≥ 30 kg/m2 according to the reference range determined by the World Health Organisation, and patients who refused to participate were excluded from the study
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 |
|---|---|---|
| Clinical periodontal measuremenetsThe periodontal assessment was performed by a single trained examiner (S.D.). A graded periodontal probe (Williams, Hu-Friedy, Chicago, IL, USA) was used to measure probing depth (PD) which was determined as the depth from the gingival margin to the bottom of the gingival sulcus/periodontal pocket, clinical attachment loss (CAL) which was calculated as the distance from the cemento-enamel junction to the bottom of the periodontal pocket and dual recording (+/-) of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) in total except third molars G | Diagnostic test | GROUP 1 (periodontally healthy ), GROUP 2 (gingivitis), GROUP 3(generalized stage I and stage II periodontitis), GROUP 4 (generalized stage III and stage IV periodontitis) |
| ELISA test from gingival crevicular fluid (GCF)GCF sampled from the buccal aspects of non-contiguous proximal regions in maxillary single-rooted teeth. In the periodontitis groups, fluid samples were taken from the two deepest pockets. In the gingivitis and periodontal healthy groups, fluid samples were obtained from areas with and without visible inflammation, respectively | Diagnostic test | GROUP 1 (periodontally healthy ), GROUP 2 (gingivitis), GROUP 3(generalized stage I and stage II periodontitis), GROUP 4 (generalized stage III and stage IV periodontitis) |
Primary outcome
Association of PD and adipokine values
Time frame: only baseline measurement the patients were seen once
correlation identification using SPSS between pocket depth and these adipokines in periodontitis patients
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 9 Feb 2024.
- Background: PubMed 11585783Loesche WJ, Grossman NS. Periodontal disease as a specific, albeit chronic, infection: diagnosis and treatment. Clin Microbiol Rev. 2001 Oct;14(4):727-52, table of contents. doi: 10.1128/CMR.14.4.727-752.2001.
- Background: PubMed 37909328Torumtay Cin G, Fenkci SM, Kilic ID, Aslan HS, Sevgican CI, Senol H. The effects of severe periodontitis on arterial stiffness using cardio-ankle vascular index in patients with type 2 diabetes. J Periodontal Res. 2024 Feb;59(1):74-83. doi: 10.1111/jre.13202. Epub 2023 Nov 1.
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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.
METİN ÇALIŞIR, PHD principal investigator
Adiyaman University
Sevde DEMİRCİ study director
Adiyaman University
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 Periodontal Diseases and Gingivitis, run by AYSAN LEKTEMUR ALPAN at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 9 Feb 2024. 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 Turkey (Türkiye). 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?
Association of PD and adipokine values (time frame: only baseline measurement the patients were seen once). 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 NCT06250764, which also lists 2 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 9 Feb 2024.