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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sensorimotor Training and Gait in Diabetic Polyneuropathy

NCT04543032

Diabetic Peripheral Neuropathy

COMPLETED NA

The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient

NCT04689971

Painful Diabetic Neuropathy

UNKNOWN PHASE2/PHASE3

Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy

NCT07306884

Diabete Mellitus Peripheral (Sensorimotor) Diabetic Polyneuropathy

NOT_YET_RECRUITING NA

Resistance Training in Patients With Diabetic Neuropathy

NCT03252132

Diabetes Mellitus, Type 2 Polyneuropathy Diabetes Diabetes Complications +3 more

COMPLETED NA

Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy

NCT04322240

Diabetic Polyneuropathy Diabetes Mellitus, Type 2

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

Group І: Control group included non-diabetic healthy males aged (40-60) years old

25(OH) vitamin D

Intervention Type OTHER

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

type 2 diabetic male not suffering from diabetic neuropathy aged(40-60) years old

Nerve Growth Factor

Intervention Type OTHER

nerve growth factor level using its corresponding ELISA kit

type2 diabetic males suffering from diabetic neuropathy aged(40_60)years old

type2 diabetic males suffering from diabetic neuropathy aged(40\_60)years old

nerve conduction studies

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nerve conduction studies

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

Intervention Type OTHER

Nerve Growth Factor

nerve growth factor level using its corresponding ELISA kit

Intervention Type OTHER

25(OH) vitamin D

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes