Effect of High-Dose NAC on Patients With DPN

Ain Shams University30 enrolled

Overview

The aim of the current study is to evaluate the efficacy and safety of high dose oral NAC (2400 mg/day divided into two doses) as an adjunct therapy on oxidative stress, inflammatory markers and clinical outcome in patients with type 2 diabetes suffering from diabetic peripheral neuropathy.

Patient written informed consent will be taken prior to study conductance * Lab assessment will be done at baseline and at the end of the study by withdrawing 7 ml of whole blood for assessment of following parameters: HbA1c, Liver \& renal functions * Inflammatory markers including: Human Nuclear factor erythroid 2-related factor (NRF2) \& Tumor necrosis factor alpha (TNF-α) using ELISA Kit * Oxidative stress markers: Glutathione Peroxidase using ELISA Kit Inflammatory and oxidative stress marker samples will be stored at -80 for further evaluation using ELISA kit at the end of the study

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Neuropathies

Interventions

Acetyl cysteineDRUG

NAC exhibits potent anti-oxidant activity in the cell through augmentation of intracellular GSH, which is a major component of the pathways by which cells are protected from OTS, and its direct scavenging activity of free radicals by providing sulfhydryl groups. Additionally, NAC treatment exhibits anti-inﬂammatory effects via inhibition of NF-κB activation and reducing subsequent cytokine production . Mitochondria-protective mechanisms of NAC may also be related to its anti-oxidant and anti-inﬂammatory properties

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males or females aged 18-50 years diagnosed with Type 2 Diabetes taking oral hypoglycemic with controlled at HbA1c (6%-7%.) 2. Patients diagnosed with Diabetic Neuropathy (by pinprick, temperature probe, ankle reflex, and vibration perception (128-Hz tuning fork) or pressure sensation (10 g monofilament test). Exclusion Criteria: 1. Patients with acute and chronic inflammatory conditions, consuming any antioxidant supplements or anti-inflammatory medicines. 2. Pregnancy or lactation or expecting to get pregnant during the study. 3. Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data. 4. Cancer patients. 5. Anyone having hypersensitivity to N-acetylcysteine. 6. Anyone already taking N-acetylcysteine.

Locations (1)

Demerdash Hospital

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

Concentration of Human Nuclear factor erythroid 2-related factor (NRF2)

Inflammatory marker

Time frame: change from baseline Human Nuclear factor erythroid 2-related factor at 3 months

Concentration of Tumor necrosis factor alpha

Inflammatory marker

Time frame: Change from baseline tumor necrosis factor alpha at 3 months

Concentration of Glutathione peroxidase

Oxidative stress markers

Time frame: Change from baseline glutathione peroxidase at 3 months

Central Contacts

Sherien Emara, TA

CONTACT

01154089169 sherienemara@hotmail.com

Sara Farid Mohamed, Lecturer

CONTACT

Data from ClinicalTrials.gov

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