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临床试验/NCT01718015
NCT01718015Unknown不适用

Neurotrophic Factors in Cerebrospinal Fluid in Diabetic Patients With Polyneuropathy

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
1
主要终点
Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood.

研究概览

简要总结

Background: The pathogenetic factors underlying development of diabetic polyneuropathy (DP) remain unclear. Reduced neurotrophic stimulation has been proposed as a possible mechanism. The neurotrophic factors IGF I and II, sCD-163, NGF, VEGF and BDNF are essential for development and regeneration of the nervous system. In earlier studies reduced concentrations of IGF-I and II in blood and reduced concentrations of NGF and BDNF in muscle and skin biopsies have been found in patients with DP.

Purpose: Our purpose is to determine the concentration and biological activity of Insulin-like Growth Factor I and II (IGF-I and II), soluble Cluster of Differentiation 163 (sCD-163), Nerve Growth Factor (NGF), Vascular Endothelial Growth Factor (VEGF) and Brain-derived Neurotropic Factor (BDNF) in cerebrospinal fluid and in blood in patients with diabetes and/or nerve disease (especially diabetic polyneuropathy) as well as in healthy control subjects. We will furthermore relate the findings to peripheral nerve function. In addition the composition of the cerebrospinal fluid will be analyzed using mass spectrometry.

Hypothesis: We hypothesize that DP develops due to reduced concentration and biological activity of neurotrophic factors. We expect the concentration of IGF-I and II, VEGF, NGF and BDNF to be reduced in cerebrospinal fluid in patients with DP compared to diabetic patients without damage to the nervous system and healthy control subjects.

Methods: Study subjects consists of patients from Department of Neurology and Department of Department of Clinical Medicine (Endocrinology and Diabetes) Aarhus University Hospital, Denmark, who are having a lumbar puncture performed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with diabetic polyneuropathy
  • Patients with diabetes without peripheral nerve disorder
  • Patients with polyneuropathies not due to diabetes
  • Patients not suffering from diabetes or nerve disease (control subjects)
  • Patients with unspecified nerve disease

排除标准

  • Other causes to the development of polyneuropathy in patients with diabetic polyneuropathy
  • Cerebral infections

结局指标

主要结局

Concentrations of IGF-I and II, sCD-163, VEGF, NGF and BDNF in cerebrospinal fluid and blood.

时间窗: november 2012 - august 2013

次要结局

  • Isokinetic dynamometry (ankle and knee at non-dominating lower extremity, elbow and wrist at dominating upper extremity)(november 2012 - august 2013)
  • Vibration and temperature thresholds (index finger on dominating arm and great toe on non-dominating leg)(november 2012 - august 2013)
  • Nerve conduction studies: Nerve velocity, Amplitude, F-waves, Motor Unit Number Estimate (dominating arm and non-dominating leg)(November 2012 - august 2013)
  • Clinical neurological examination including tendon reflexes, muscle strength and sensation.(november 2012 - august 2013)

研究者

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

Mia Jørgensen

Medical Research Year Student

Aarhus University Hospital

研究点 (1)

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