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NCT Number: NCT07236723

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 .

Exclusion criteria

  • 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.

Treatment and study plan

nerve conduction studies

Other

Assessment of neuropathy by nerve conduction studies of sural and tibial nerves in both lower extremities.

Nerve Growth Factor

Other

nerve growth factor level using its corresponding ELISA kit

25(OH) vitamin D

Other

25(OH) vitamin D serum level using its corresponding ELISA kit

Primary outcomes

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

    Time frame: one year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa Nasry Elbadry, physiology demonstrator

CONTACT

[email protected]

02+01126060796

Sponsors and collaborators

Lead sponsor

Aswan University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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