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Набор скоро начнётся NCT07236723

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

— Наблюдательное Diabetic Neuropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: nerve conduction studies, Nerve Growth Factor, 25(OH) vitamin D.
Кому может быть актуально
Состояния в реестре: Diabetic Neuropathy. Базовые параметры: 40 лет — 60 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Обзор

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

Подробное описание

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.

Вмешательства

  • Другое nerve conduction studies
    Assessment of neuropathy by nerve conduction studies of sural and tibial nerves in both lower extremities.
  • Другое Nerve Growth Factor
    nerve growth factor level using its corresponding ELISA kit
  • Другое 25(OH) vitamin D
    25(OH) vitamin D serum level using its corresponding ELISA kit

Первичные конечные точки

  • study the relation of vitamin d and nerve growth factor with nerve conduction studies in type 2 diabetic neuropathy male patients [Срок оценки: one year]

Критерии участия

Критерии включения

  • 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 .

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Египет · 2 центра
  • Aswan university hospital — Aswān
  • Aswan university hospital — Aswān

Публикации

  • 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. PMID 38376038
  • 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. PMID 32844212

Идентификаторы

NCT: NCT07236723 · diabetic neuropathy

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗