- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06266247
How Sirtuin Levels Change During Behçet Disease
Relationship of Inflammation Markers and Sirtuin Levels Disease Activity in Patients With Behcet's Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Karaman, Turkey
- Karamanoglu Mehmetbey University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Patients diagnosed with Behçet's disease between the ages of 18-65 who come to the Rheumatology Polyclinic for their normal routine check-up.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: patients
|
Tnf alpha, sirtuin and il-6 levels will be examined in patients with Behcet's disease using biological drugs and not using biological drugs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From enrollment to the end of treatment at 6 months"
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Eye Diseases
- Genetic Diseases, Inborn
- Stomatognathic Diseases
- Mouth Diseases
- Uveitis, Anterior
- Panuveitis
- Uveitis
- Uveal Diseases
- Hereditary Autoinflammatory Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Inflammation
- Behcet Syndrome
- Vasculitis
Other Study ID Numbers
- 06-2023/16
- KMU-BAP (Other Identifier: KMU)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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