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

A

Aswan University

Status

Not yet enrolling

Conditions

Diabetic Neuropathy

Treatments

Other: 25(OH) vitamin D
Other: Nerve Growth Factor
Other: nerve conduction studies

Study type

Observational

Funder types

Other

Identifiers

NCT07236723
diabetic neuropathy

Details and patient eligibility

About

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

Full description

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.

Enrollment

57 estimated patients

Sex

Male

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

57 participants in 3 patient groups

control group
Description:
Group І: Control group included non-diabetic healthy males aged (40-60) years old
Treatment:
Other: 25(OH) vitamin D
type 2 diabetic male not suffering from diabetic neuropathy aged(40-60) years old
Description:
type 2 diabetic male not suffering from diabetic neuropathy aged(40-60) years old
Treatment:
Other: Nerve Growth Factor
type2 diabetic males suffering from diabetic neuropathy aged(40_60)years old
Description:
type2 diabetic males suffering from diabetic neuropathy aged(40\_60)years old
Treatment:
Other: nerve conduction studies

Trial contacts and locations

2

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Central trial contact

Marwa Nasry Elbadry, physiology demonstrator

Data sourced from clinicaltrials.gov

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