Behçet DiseaseNCT06266247
How Sirtuin Levels Change During Behçet Disease
A study testing Take blood samples in people with Behçet Disease and Inflammation, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
Our primary aim in our study is to evaluate the relationship between the activity, which will be evaluated by clinical and standard phase reactants, and the IL-6 and TNF-α levels, which will be measured in serum, in Behçet\'s patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Behçet Disease, Inflammation, Vasculitis
- What is being tested?
- Take blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 30 Oct 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Behçet's disease between the ages of 18-65 who come to the Rheumatology Polyclinic for their normal routine check-up.
Who cannot join
- Suffer from other arthritis or joint diseases;
- Combined with severe liver and kidney function damage or metabolic diseases (such as thyroid and parathyroid diseases), affecting bone metabolism;
- Combined with serious cardiovascular and cerebrovascular diseases or chronic kidney diseases;
- Combined with tumour and bone metastasis;
- Taking anticancer drugs or other drugs that affect bone metabolism;
- Pregnant or lactating women;
- Exclude other autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship of Inflammation Markers and Sirtuin Levels Disease Activity in Patients With Behcet's Disease
Our primary aim in our study is to evaluate the relationship between the activity, which will be evaluated by clinical and standard phase reactants, and the IL-6 and TNF-α levels, which will be measured in serum, in Behçet\'s patients. Our secondary aim was to evaluate Sirtuin-1 in Behcet\'s patients and compare it with the normal population. Our third aim is to find out whether there is a relationship between these values and organ involvement.
Read the detailed description
Behçet\'s disease (BD) is a systemic disease that has a long-term course with attacks, can involve many organs, and whose main pathology is vasculitis. For the first time in 1937 It was defined by Prof. Dr. Hulusi Behçet as a three-symptom complex consisting of hypopyonous uveitis along with oral and genital ulcers.
In recent years, especially as a result of developments in molecular biology, new information obtained about the structure and functions of immune system elements has revealed that the immune system plays an important role in the onset or course of the disease. Cytokines [such as IL-2, IL-6, IL-8, IL-12, Tumor Necrosis Factor-alpha (TNF-α) and Interferongama (IFN-γ)produced by Th-1 lymphocytes] that play important roles in inflammation in BD. It has been reported that the level of proinflammatory cytokines increases especially during the active period of the disease. It has been suggested that these cytokines may cause acute inflammatory tissue damage by causing neutrophil activation.
Sirtuins are known to be from the protein deacetylase and adenosine diphosphate (ADP)-ribosyl transferase protein families. Seven Sirtuin types have been identified in mammals (SIRT 1-7). Mammalian sirtuins can be affected in many physiological events such as metabolism, aging, cancer, and inflammation. Sirtuin 1 (SIRT1), a nicotinamide adenine dinucleotide (NAD+)-dependent histone deacetylase, has been reported to participate in the regulation of various biological processes such as energy balance, inflammation, oxidative stress, and mitochondrial biogenesis.
Our aim here is to compare cytokine levels according to organ involvement, drug used and to evaluate disease progression.
Blood samples for serum for cytokines and plasma for sirtuin will be taken from patients diagnosed with Behçet\'s disease between the ages of 18-65 who come to the Rheumatology Polyclinic for their normal routine check-up. The obtained samples will be stored at -80 °C until the blood of all patients is collected. In the control group, blood will be taken on a voluntary basis from people of appropriate age and gender who come to the polyclinic and do not have any inflammatory disease, and from hospital staff who do not have any health problems and do not use any medication.
All patients\' name, surname, age, gender, family history of Behçet\'s disease, smoking-alcohol use, height-weight, additional diseases and medications used for Behçet\'s disease will be questioned. Blood pressure measurement, detailed physical and dermatological examination will be performed. Behçet\'s patients will be questioned in terms of oral aphthous ulcers, genital ulcers, erythema nodosum-like lesions, papulopustular lesions, arthritis, arthralgia, uveitis, vascular involvement, neurological involvement and gastrointestinal involvement.
The disease activity of Behçet patients at the time of admission will be determined using the Behçet Disease activity form.
Descriptive statistical methods (mean, standard deviation, median, frequency, ratio, minimum, maximum) will be used when evaluating study data. The suitability of quantitative data for normal distribution will be tested with the Kolmogorov-Smirnov and Shapiro-Wilk tests. Independent t Test will be used for two-group comparisons of normally distributed quantitative data, and Mann Whitney U test will be used for two-group comparisons of non-normally distributed data. One-way Anova Test was used for comparisons of three or more normally distributed groups, and Bonferroni test was used for pairwise comparisons. The Kruskal Wallis test will be used for comparisons of three or more groups that do not show normal distribution, and the Bonferroni-Dunn test will be used for pairwise comparisons. Pearson Chi-Square Test and Fisher\'s Exact Test will be used in comparisons of qualitative data. Spearman\'s Correlation Analysis will be used to evaluate the relationships between quantitative variables. Significance will be evaluated at at least p\<0.05. (SPSS) program will be used for the evaluation
- Conditions
- Behçet Disease, Inflammation, Vasculitis
- Being tested
- Take blood samples
- Keywords
- Behçet, inflammation
- Medical subject headings
- Behcet Syndrome, Inflammation, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take blood samplesDiagnostic test
Tnf alpha, sirtuin and il-6 levels will be examined in patients with Behcet\&#39;s disease using biological drugs and not using biological drugs
| Study group | Role | What they receive |
|---|---|---|
| patients | Other | 1. Group: Behcet patients
2. Group: Healty people Receives: Diagnostic Test: Take blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our primary aim is to evaluate the relationship between the activity to be evaluated with clinical and standard acute phase reactants and the IL-6 and TNF-α levels to be measured in serum in Behçet's patients.
Since Behçet's disease is an inflammatory disease, immediate blood samples will be taken from patients presenting to the outpatient clinic. Acute phase reactants, tnf-alpha levels and interleukin-6 levels will be measured. Behçet's disease current activity form 2006 (BDCAF-2006) will be filled and disease activity levels will be evaluated. BDCAF-2006 and acute phase reactants, tnf-alpha levels and interleukin-6 levels will be compared. The same comparison will be made with acute phase reactants, tnf-alpha levels and interleukin-6 levels in the blood obtained from the control group. The difference between both groups will be evaluated
Measured: From enrollment to the end of treatment at 6 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Jan 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Hilal Ecesoy, MD, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266247
- Sponsor's protocol ID
- 06-2023/16
- Other IDs
- KMU-BAP
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Inflammation Markers and Sirtuin Levels Disease Activity in Patients With Behcet's Disease
- ClinicalTrials.gov ID
- NCT06266247
- Acronym / sponsor ID
- 06-2023/16
- Conditions
- Behçet Disease, Inflammation, Vasculitis
- Keywords
- Behçet, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 20 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.
Our primary aim in our study is to evaluate the relationship between the activity, which will be evaluated by clinical and standard phase reactants, and the IL-6 and TNF-α levels, which will be measured in serum, in Behçet\'s patients. Our secondary aim was to evaluate Sirtuin-1 in Behcet\'s patients and compare it with the normal population. Our third aim is to find out whether there is a relationship between these values and organ involvement.
Detailed description
Behçet\'s disease (BD) is a systemic disease that has a long-term course with attacks, can involve many organs, and whose main pathology is vasculitis. For the first time in 1937 It was defined by Prof. Dr. Hulusi Behçet as a three-symptom complex consisting of hypopyonous uveitis along with oral and genital ulcers.
In recent years, especially as a result of developments in molecular biology, new information obtained about the structure and functions of immune system elements has revealed that the immune system plays an important role in the onset or course of the disease. Cytokines [such as IL-2, IL-6, IL-8, IL-12, Tumor Necrosis Factor-alpha (TNF-α) and Interferongama (IFN-γ)produced by Th-1 lymphocytes] that play important roles in inflammation in BD. It has been reported that the level of proinflammatory cytokines increases especially during the active period of the disease. It has been suggested that these cytokines may cause acute inflammatory tissue damage by causing neutrophil activation.
Sirtuins are known to be from the protein deacetylase and adenosine diphosphate (ADP)-ribosyl transferase protein families. Seven Sirtuin types have been identified in mammals (SIRT 1-7). Mammalian sirtuins can be affected in many physiological events such as metabolism, aging, cancer, and inflammation. Sirtuin 1 (SIRT1), a nicotinamide adenine dinucleotide (NAD+)-dependent histone deacetylase, has been reported to participate in the regulation of various biological processes such as energy balance, inflammation, oxidative stress, and mitochondrial biogenesis.
Our aim here is to compare cytokine levels according to organ involvement, drug used and to evaluate disease progression.
Blood samples for serum for cytokines and plasma for sirtuin will be taken from patients diagnosed with Behçet\'s disease between the ages of 18-65 who come to the Rheumatology Polyclinic for their normal routine check-up. The obtained samples will be stored at -80 °C until the blood of all patients is collected. In the control group, blood will be taken on a voluntary basis from people of appropriate age and gender who come to the polyclinic and do not have any inflammatory disease, and from hospital staff who do not have any health problems and do not use any medication.
All patients\' name, surname, age, gender, family history of Behçet\'s disease, smoking-alcohol use, height-weight, additional diseases and medications used for Behçet\'s disease will be questioned. Blood pressure measurement, detailed physical and dermatological examination will be performed. Behçet\'s patients will be questioned in terms of oral aphthous ulcers, genital ulcers, erythema nodosum-like lesions, papulopustular lesions, arthritis, arthralgia, uveitis, vascular involvement, neurological involvement and gastrointestinal involvement.
The disease activity of Behçet patients at the time of admission will be determined using the Behçet Disease activity form.
Descriptive statistical methods (mean, standard deviation, median, frequency, ratio, minimum, maximum) will be used when evaluating study data. The suitability of quantitative data for normal distribution will be tested with the Kolmogorov-Smirnov and Shapiro-Wilk tests. Independent t Test will be used for two-group comparisons of normally distributed quantitative data, and Mann Whitney U test will be used for two-group comparisons of non-normally distributed data. One-way Anova Test was used for comparisons of three or more normally distributed groups, and Bonferroni test was used for pairwise comparisons. The Kruskal Wallis test will be used for comparisons of three or more groups that do not show normal distribution, and the Bonferroni-Dunn test will be used for pairwise comparisons. Pearson Chi-Square Test and Fisher\'s Exact Test will be used in comparisons of qualitative data. Spearman\'s Correlation Analysis will be used to evaluate the relationships between quantitative variables. Significance will be evaluated at at least p\<0.05. (SPSS) program will be used for the evaluation
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Other | Diagnostic Test: Take blood samples1. Group: Behcet patients 2. Group: Healty people |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with Behçet's disease between the ages of 18-65 who come to the Rheumatology Polyclinic for their normal routine check-up.
Key exclusion criteria (7 listed)
- Suffer from other arthritis or joint diseases;
- Combined with severe liver and kidney function damage or metabolic diseases (such as thyroid and parathyroid diseases), affecting bone metabolism;
- Combined with serious cardiovascular and cerebrovascular diseases or chronic kidney diseases;
- Combined with tumour and bone metastasis;
- Taking anticancer drugs or other drugs that affect bone metabolism;
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 |
|---|---|---|
| Take blood samplesTnf alpha, sirtuin and il-6 levels will be examined in patients with Behcet\&#39;s disease using biological drugs and not using biological drugs | Diagnostic test | patients |
Primary outcome
Our primary aim is to evaluate the relationship between the activity to be evaluated with clinical and standard acute phase reactants and the IL-6 and TNF-α levels to be measured in serum in Behçet's patients.
Time frame: From enrollment to the end of treatment at 6 months"
Since Behçet's disease is an inflammatory disease, immediate blood samples will be taken from patients presenting to the outpatient clinic. Acute phase reactants, tnf-alpha levels and interleukin-6 levels will be measured. Behçet's disease current activity form 2006 (BDCAF-2006) will be filled and disease activity levels will be evaluated. BDCAF-2006 and acute phase reactants, tnf-alpha levels and interleukin-6 levels will be compared. The same comparison will be made with acute phase reactants, tnf-alpha levels and interleukin-6 levels in the blood obtained from the control group. The difference between both groups will be evaluated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take blood samples in people with Behçet Disease and Inflammation, run by Karamanoğlu Mehmetbey University 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 7 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: status not confirmed, as of the sponsor's last update on 20 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?
Results are not available in the source record.
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?
Our primary aim is to evaluate the relationship between the activity to be evaluated with clinical and standard acute phase reactants and the IL-6 and TNF-α levels to be measured in serum in Behçet's patients. (time frame: From enrollment to the end of treatment at 6 months"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.