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临床试验/NCT06266247
NCT06266247Unknown不适用

Relationship of Inflammation Markers and Sirtuin Levels Disease Activity in Patients With Behcet's Disease

Karamanoğlu Mehmetbey University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with Behçet's disease between the ages of 18-65 who come to the Rheumatology Polyclinic for their normal routine check-up.

排除标准

  • 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

研究组 & 干预措施

patients

Other
  1. Group: Behcet patients
  2. Group: Healty people

干预措施: Take blood samples (Diagnostic Test)

结局指标

主要结局

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.

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Karamanoğlu Mehmetbey University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Hilal Ecesoy, MD

Clinical profesor

Karamanoğlu Mehmetbey University

研究点 (2)

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