Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06266247 |
| Other study ID # |
06-2023/16 |
| Secondary ID |
KMU-BAP |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2024 |
| Est. completion date |
October 30, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Karamanoglu Mehmetbey University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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
