TGF β 1 Expression Related Gene Polymorphism and Their Association With Clinical Types of Leprosy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Detection of serum TGF β1
研究概览
简要总结
Leprosy is one of the oldest human infectious diseases. It is a chronic infectious contagious, granulomatous disease caused by intracellular bacillus.
Mycobacterium leprae, this chronic granulomatous disease presents symptoms that mainly affected the skin, the nervous system and the reticuloendothelial system, also other systems can be affected, such as the upper respiratory tract, bones and joints, eyes and adrenal glands.
TGF- β is a pleiotropic cytokine that employs several functions on different types of cells. The effect of other cytokines may finally modulate the cellular response in the presence of TGF- β, causing a different effect depending on the activation state of the cell involved. In addition, TGF- β promotes the healing of inflamed tissue through the stimulation and regulation of extracellular matrix by fibroblasts, in addition to inducing the proliferation of endothelial cells required for angiogenesis. Thus, TGF- β is able to regulate the expression of other growth factors, increasing their level of activity.
详细描述
The spectrum of clinical and histopathological manifestations reflects the immune response elicited by the microorganism in the host leprosy classified into polar groups:
Lepromatous (LL) and Tuberculoid (TT); and borderline spectrum: Borderline Tuberculoid (BT), Borderline Borderline (BB) and Borderline Lepromatous (BL). This classification, proposed by Ridley and Jopling This classification widely used in clinical, immunological, microbiological, and histopathological aspects. While The World Health Organization classifies leprosy clinically as multibacillary and paucibacillary, according to the number of skin lesions and nerve involvement.
In the tuberculoid form of leprosy (paucibacillary), the individual manifests an intense cell-mediated immune response that prevents proliferation of the bacillus, whereas the cell-mediated immune response is compromised in the lepromatous form (multibacillary) contributing to multiplication of the bacillus. In the intermediate forms,the patients exhibit characteristics that vary between the two types.
Leprosy is measured the first disease to be categorized based on the host's immune response. The clinical symptoms of leprosy vary from one patient to another based on the spectrum of disease but more importantly on the type of host's immune response to the bacteria. Both innate and acquired immune responses have been associated with leprosy, but the disease is typically described by the side of a Th1/Th2 response.
Patients with TT are decided by a relevant T-cell immune response, including interleukin-2 (IL-2), IL-4, IL-6, IL-10, interferon-γ (IFN-γ), tumor necrosis factor (TNF), and IL-17 and lymphotoxin, marked by some neural or cutaneous lesions with a few or no bacilli.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes with leprosy.
- •Age above 18 years.
- •patients on multidrug therapy of leprosy.
排除标准
- •Patients with other dermatological disease.
- •Patients with leprosy reaction.
- •Pregnancy and lactation.
- •Patients with autoimmune disease.
结局指标
主要结局
Detection of serum TGF β1
时间窗: One Year
Detection of serum TGF β1 in leprosy patients and Correlate them with different clinical types of leprosy by taking Blood Samples will be collected from the patients to detect TGF β1gene by DNA extraction and SNP genotyping - Genomic DNA will be extracted from peripheral blood samples, then the polymorphism of the TGF β1 gene marker will be selected, The Blood Samples will be collected from the patients before and after treatment with multidrug therapy of leprosy to detect the level of TGF β1 concentrations by ELISA.
次要结局
未报告次要终点
研究者
Gehad Adel Abd El-Sabour Mohammed
Specialist of Dermatology
Aswan University