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临床试验/NCT07236723
NCT07236723尚未招募不适用

Vitamin D, Nerve Growth Factor and Nerve Conduction Studies in Adult Male Type 2 Diabetic Neuropathy Patients

Aswan University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
57
试验地点
1
主要终点
study the relation of vitamin d and nerve growth factor with nerve conduction studies in type 2 diabetic neuropathy male patients

研究概览

简要总结

study the relationship of vitamin d with nerve growth factor level and nerve conduction studies in adult male type 2 diabetic neuropathy patients

详细描述

Diabetic peripheral neuropathy (DPN) is one of the most frequent microvascular complications of both type1 (T1DM) and type2 diabetes mellitus (T2DM) . It involves damage to the peripheral nerves, leading to symptoms such as numbness, tingling, pain, and loss of sensation in the extremities, especially the feet and hands . It is the primary risk factor for lower limb ulcers, amputations and consequent disabling, that can significantly affect a person's quality of life.

Unfortunately, the exact pathogenesis of diabetic neuropathy is complex and multifactorial. However, several studies have shown that increased levels of blood glucose leads to several neuronal changes as accumulation of advanced glycation end products, mitochondrial impairment and DNA damage. Furthermore, Vitamin D deficiency is more common in people with T2DM, contributing its pathogenesis in many ways, including impairment of insulin secretion and increasing insulin resistance. Moreover, previous studies reported that low level of vitamin D is correlated with the presence and severity of sensory neuropathy . However, its pathogenesis has not yet been established.

Nerve growth factor (NGF) is a neurotrophic factor playing a major role in adult peripheral nerve system. It works by increasing nerve cell regeneration and decreasing degeneration, so NGF decreased levels induce peripheral nerve lesion in diabetic patients.

Several studies indicate that vitamin D may play a role in nutrition and protection of peripheral nerves as nerve cells and glial cells rich in vitamin D receptors, So vitamin D may have a potential effect in DPN by neuro-protection as it protect against apoptosis and degeneration, as well as it can trigger production of NGF helping preservation of neurons. Thus, we hypothesize that vitamin D, by regulating NGF expression, could help nerve regeneration and improve outcomes in patients with DPN.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Adult male patients 40 -65 years' old who have type 2 diabetes mellitus on oral hypoglycemic , non-diabetic healthy subjects of matched age and type 2male diabetic neuropathy patients of matched age .

排除标准

  • Cardiac patients.
  • Patients who have transient ischemic attack or stroke.
  • Patients with inflammatory rheumatic diseases.
  • Patients with malignant diseases.
  • Hyperparathyroidism.
  • Hypothyroidism.
  • Renal impairment with renal replacement therapy.
  • Liver diseases.
  • Patients on vitamin D supplementation.
  • Patients on vitamin B12 supplementation.

结局指标

主要结局

study the relation of vitamin d and nerve growth factor with nerve conduction studies in type 2 diabetic neuropathy male patients

时间窗: one year

1. Difference in vitamin D level between diabetic neuropathy patients, diabetic patients without neuropathy and healthy subjects. 2. Difference in serum nerve growth factor level between diabetic neuropathy patients, diabetic patients without neuropathy and healthy subjects.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Nasry Elbadry

Instructor of medical physiology

Aswan University

研究点 (1)

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