Effects of Cocarnit on Macrophages Polarization in Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in macrophages activation after 30-days Cocarnit administration
研究概览
简要总结
Cocarnit is a metabolic complex containing disodium adenosine triphosphate trihydrate, cocarboxylase, cyanocobalamin and nicotinamide.
Aim: To test the effects of Cocarnit on pro- and anti-inflammatory activation of blood-derived monocytes-macrophages from Type 2 diabetic patients.
Study design: Measurements of stimulated and basal secretion of TNF-alpha and CCl-18 before and at 2 and 4 hours after single intramuscular administration of Cocarnit at first day and after 30 days of follow-up in 40 Type 2 diabetic patients with/without polyneuropathy.
Methods: The profile of monocyte polarization was determined in vitro in primary cell culture of blood-derived monocytes-macrophages after pro-inflammatory stimulation by bacterial lipopolysaccharide and after anti-inflammatory stimulation by interleukin-4, according to tumor necrosis factor (TNF) and CCL18 chemokine secretion, respectively.
详细描述
Diabetes mellitus (DM) is the most common endocrine disease, and its social significance is associated with early disability and high mortality. Indicators of diabetes mellitus decompensation are its chronic complications, the most common one is a diabetic polyneuropathy. In recent years a large number of papers demonstrate the role of the chronic inflammatory process in the development of type 2 DM. Macrophages play a key role in the development of the inflammatory response. Macrophages are the main cells producing pro-inflammatory cytokines, which cause a cascade of reactions leading to the development of insulin resistance, that is the important factor of the pathogenesis of type 2 DM. There are two main types of activation of macrophages under the influence of T-helper cells 1 and 2. The first type is classical activation of macrophages that is a response to pro-inflammatory stimuli, such as interferon-gamma or lipopolysaccharide. Classically activated macrophages are well studied and characterized by the secretion of reactive oxygen species and pro-inflammatory cytokines such as TNF-alpha, interleukins 1,6,12. The second type is alternative activation of macrophages that is the result of the influence of anti-inflammatory cytokines, such as interleukins 4,10,13 or anti-inflammatory mediators, for example, glucocorticoids. The result of alternative activation of macrophages is the expression of anti-inflammatory cytokines such as antagonist receptor interleukin 1, interleukin 10, CCL18, haptoglobin receptor CD163, scavenger receptor type1.
Cocarnit is a metabolic complex containing disodium adenosine triphosphate trihydrate 10mg, cocarboxylase 50mg, cyanocobalamin 500mg and nicotinamide 20mg.
The aim of the present study is to test the effects of Cocarnit on pro- and anti-inflammatory activation of blood-derived monocytes-macrophages from Type 2 diabetic patients.
The profile of monocyte polarization was determined in vitro in primary cell culture of blood-derived monocytes-macrophages after pro-inflammatory stimulation by bacterial lipopolysaccharide and after anti-inflammatory stimulation by interleukin-4, according to tumor necrosis factor (TNF) and CCL18 chemokine secretion, respectively.
Study design: Open label study included 40 Type 2 diabetic patients divided into two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus newly-diagnosed (for group 1)
- •Type 2 diabetes and diabetic polyneuropathy (for group 2)
- •Availability of informed consent to participate in the study
排除标准
- •Refusal to sign informed consent to participate in the study
- •Presence of chronic diseases that require constant medication, except preparations for the correction of diabetes
- •Individual intolerance to the preparation
- •Infectious disease or fever during the period of inclusion
- •Refusal to take the preparation during the study
- •Non-compliance with inclusion criteria
结局指标
主要结局
Change in macrophages activation after 30-days Cocarnit administration
时间窗: 30 days
Measurement of serum-induced basal and stimulated by bacterial lipopolysaccharide secretion of TNF-alpha and basal and stimulated by IL-4 secretion of CCL-18 in primary cell culture of blood-derived monocytes-macrophages after 30 days of Cocarnit administration. Changes are expressed in % of baseline secretion before the preparation administration.
Change in macrophages activation after single Cocarnit administration
时间窗: 4 hours
Measurement of serum-induced basal and stimulated by bacterial lipopolysaccharide secretion of TNF-alpha and basal and stimulated by IL-4 secretion of CCL-18 in primary cell culture of blood-derived monocytes-macrophages before and after 2 and 4 hours of Cocarnit administration. Changes are expressed in % of baseline secretion before the preparation administration.
次要结局
未报告次要终点