Diabetic NeuropathyNCT07236723
Vitamin D, Nerve Growth Factor and Nerve Conduction Studies in Adult Male Type 2 Diabetic Neuropathy Patients
An observational study of Diabetic Neuropathy, run by Aswan University at 2 sites in Egypt.
Trial summary
study the relationship of vitamin d with nerve growth factor level and nerve conduction studies in adult male type 2 diabetic neuropathy patients Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- nerve conduction studies, Nerve Growth Factor and 25(OH) vitamin D
- How many people
- 57 participants
- Where
- 2 sitesEgypt
- Study dates
- Dec 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Group І: Control group included non-diabetic healthy males. Group П: Type 2 male diabetic patients not suffering from diabetic neuropathy in Aswan University Hospital of matched age. Group III: Type 2 male diabetic patients suffering from diabetic neuropathy in Aswan University Hospital of matched age.
Who may be able to join
- 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 .
Who cannot join
- Cardiac patients.
- Patients who have transient ischemic attack or stroke.
- Patients with inflammatory rheumatic diseases.
- Patients with malignant diseases.
- Hyperparathyroidism.
- Hypothyroidism.
Show all 10Show fewer
- Renal impairment with renal replacement therapy.
- Liver diseases.
- Patients on vitamin D supplementation.
- Patients on vitamin B12 supplementation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Aswan university hospital
Aswān, Aswan Governorate, 81157
Huda Ahmed Elsaid, lecturer, 02+01001478843, huda_ahmed@aswu.edu.eg
Marwa Nasry Elbadry, instructor
Aswan university hospital
Aswān, Aswan Governorate, Aswan
About this study
study the relationship of vitamin d with nerve growth factor level and nerve conduction studies in adult male type 2 diabetic neuropathy patients
Read the detailed 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.
- Conditions
- Diabetic Neuropathy
- Being tested
- nerve conduction studies, Nerve Growth Factor, 25(OH) vitamin D
- Keywords
- vitamin d, nerve growth factor and diabetic neuropathy
- Medical subject headings
- Diabetic Neuropathies, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve conduction studiesOther
Assessment of neuropathy by nerve conduction studies of sural and tibial nerves in both lower extremities.
Nerve Growth FactorOther
nerve growth factor level using its corresponding ELISA kit
25(OH) vitamin DOther
25(OH) vitamin D serum level using its corresponding ELISA kit
| Study group | Role | What they receive |
|---|---|---|
| control group | Group І: Control group included non-diabetic healthy males aged (40-60) years old Receives: Other: 25(OH) vitamin D | |
| type 2 diabetic male not suffering from diabetic neuropathy aged(40-60) years old | type 2 diabetic male not suffering from diabetic neuropathy aged(40-60) years old Receives: Other: Nerve Growth Factor | |
| type2 diabetic males suffering from diabetic neuropathy aged(40_60)years old | type2 diabetic males suffering from diabetic neuropathy aged(40_60)years old Receives: Other: nerve conduction studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
study the relation of vitamin d and nerve growth factor with nerve conduction studies in type 2 diabetic neuropathy male patients
- 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Nasry Elbadry, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236723
- Sponsor's protocol ID
- diabetic neuropathy
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no need
Publications
Shafiee A, Rafiei MA, Jafarabady K, Eskandari A, Abhari FS, Sattari MA, Amini MJ, Bakhtiyari M. Effect of cannabis use on blood levels of brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF): A systematic review and meta-analysis. Brain Behav. 2024 Jan;14(1):e3340. doi: 10.1002/brb3.3340.
PubMed 38376038Pittas AG, Jorde R, Kawahara T, Dawson-Hughes B. Vitamin D Supplementation for Prevention of Type 2 Diabetes Mellitus: To D or Not to D? J Clin Endocrinol Metab. 2020 Dec 1;105(12):3721-33. doi: 10.1210/clinem/dgaa594.
PubMed 32844212
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D, Nerve Growth Factor and Nerve Conduction Studies in Adult Male Type 2 Diabetic Neuropathy Patients
- ClinicalTrials.gov ID
- NCT07236723
- Acronym / sponsor ID
- diabetic neuropathy
- Conditions
- Diabetic Neuropathy
- Keywords
- vitamin d, nerve growth factor and diabetic neuropathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
study the relationship of vitamin d with nerve growth factor level and nerve conduction studies in adult male type 2 diabetic neuropathy patients
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: 25(OH) vitamin DGroup І: Control group included non-diabetic healthy males aged (40-60) years old |
| type 2 diabetic male not suffering from diabetic neuropathy aged(40-60) years old | – | Other: Nerve Growth Factortype 2 diabetic male not suffering from diabetic neuropathy aged(40-60) years old |
| type2 diabetic males suffering from diabetic neuropathy aged(40_60)years old | – | Other: nerve conduction studiestype2 diabetic males suffering from diabetic neuropathy aged(40_60)years old |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group І: Control group included non-diabetic healthy males. Group П: Type 2 male diabetic patients not suffering from diabetic neuropathy in Aswan University Hospital of matched age. Group III: Type 2 male diabetic patients suffering from diabetic neuropathy in Aswan University Hospital of matched age.
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (10 listed)
- Cardiac patients.
- Patients who have transient ischemic attack or stroke.
- Patients with inflammatory rheumatic diseases.
- Patients with malignant diseases.
- Hyperparathyroidism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nerve conduction studiesAssessment of neuropathy by nerve conduction studies of sural and tibial nerves in both lower extremities. | Other | type2 diabetic males suffering from diabetic neuropathy aged(40_60)years old |
| Nerve Growth Factornerve growth factor level using its corresponding ELISA kit | Other | type 2 diabetic male not suffering from diabetic neuropathy aged(40-60) years old |
| 25(OH) vitamin D25(OH) vitamin D serum level using its corresponding ELISA kit | Other | control group |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 38376038Shafiee A, Rafiei MA, Jafarabady K, Eskandari A, Abhari FS, Sattari MA, Amini MJ, Bakhtiyari M. Effect of cannabis use on blood levels of brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF): A systematic review and meta-analysis. Brain Behav. 2024 Jan;14(1):e3340. doi: 10.1002/brb3.3340.
- Results publication: PubMed 32844212Pittas AG, Jorde R, Kawahara T, Dawson-Hughes B. Vitamin D Supplementation for Prevention of Type 2 Diabetes Mellitus: To D or Not to D? J Clin Endocrinol Metab. 2020 Dec 1;105(12):3721-33. doi: 10.1210/clinem/dgaa594.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. no need
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Neuropathy, run by Aswan University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa Nasry Elbadry, physiology demonstrator (02+01126060796, marwanasry666@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07236723, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.