Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction: Effect of Tadalafil Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ِAssessments of endothelial nitric oxide synthase In diabetes mellitus
研究概览
简要总结
Erectile dysfunction (ED) is defined as penile erection that is insufficient and unsustainable for a satisfactory sexual performance.
The etiology of ED is multifactorial including chronic diseases such as hypertension, diabetes mellitus and coronary artery disease However, the main underlying cause is degenerative changes that result in endothelial dysfunction
详细描述
Diabetes leads to endothelial dysfunction and a pro-inflammatory state, which reduces the usability and activity of nitric oxide (NO). NO is a powerful force for sustaining penile blood flow.
Diabetes is an estab¬lished risk factor for sexual dysfunction in men; a three-fold increased risk of erectile dysfunction (ED) was documented in diabetics compared with non-diabetic men.
In smooth muscles, NO activates guanyl cyclase and increases cyclic guanosine monophosphate (cGMP) concentration. cGMP activates certain intracellular protein kinases that phosphorylate receptor proteins. Activated protein kinases open the potassium channels and increase the influx of potassium and block the influx of calcium by inhibiting calcium channels. This leads to hyperpolarization and relaxation of smooth muscle. Reduced arteriolar resistance leads to sinusoidal spaces filled with blood. These enlarged sinusoids further increase the intracavernosal pressure by blocking the venous return and producing a rigid erection. cGMP is converted to GMP by phosphodiesterase, which is inhibited by phosphodiesterase 5 (PDE-5) inhibitors.
(NO) has vasodilatory properties and balances RhoA/Rho-kinase-mediated vasoconstriction, which is a predominant mediator of the physiologic induction and maintenance of erections.
Evidences show that functional polymorphisms within endothelial NO synthase (eNOS) gene interfere with normal erectile function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Diabetic patients with ED.
- •Using tadalafil 5mg
排除标准
- •Patients with history of pelvic trauma or major pelvic surgical intervention.
- •Patients with hypogonadism and hyperprolactinemia.
- •Patients with chronic liver disease or cardio vascular system diseases.
- •History of chronic intake of central nervous system, anti-androgen drugs or other drugs as Tramadol.
- •Patients with non-vasculogenic Erectile dysfunction
结局指标
主要结局
ِAssessments of endothelial nitric oxide synthase In diabetes mellitus
时间窗: 24 hours
About 2 milliliter of blood will be evacuated into EDTA containing tubes and will be stored at-80c till the time of genetic assay of nitric oxide synthase gene polymorphism using RELP - PCR technique .
次要结局
- Tadalafil 5milligram (tablets) therapy in diabetic patients(3 months from starting the therapy)