NCT07236723

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

November 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 15, 2025

Last Update Submit

November 15, 2025

Conditions

Keywords

vitamin d, nerve growth factor and diabetic neuropathy

Outcome Measures

Primary Outcomes (1)

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

    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.

    one year

Study Arms (3)

control group

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

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

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

Other: nerve conduction studies

Interventions

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

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

nerve growth factor level using its corresponding ELISA kit

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

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

control group

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aswan university hospital

Aswān, Aswan Governorate, 81157, Egypt

Location

Aswan university hospital

Aswān, Aswan Governorate, Aswan, Egypt

Location

Related Publications (2)

  • 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.

  • Pittas 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 Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Diabetic NeuropathiesHereditary Sensory and Autonomic Neuropathies

Interventions

Nerve Growth FactorVitamin D

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesNervous System MalformationsHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Nerve Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsNerve Tissue ProteinsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Marwa Nasry Elbadry, physiology demonstrator

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of medical physiology

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 19, 2025

Study Start

December 1, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations