Effect of High-Dose NAC on Patients With DPN

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of High-Dose N-acetyl Cysteine (NAC) on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy (DPN)

Conditions
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Diabetic Neuropathies

Intervention / Treatment
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* Drug: Acetyl cysteine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged 18-50 years diagnosed with Type 2 Diabetes taking oral hypoglycemic with controlled at HbA1c (6%-7%.) 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: Patients with acute and chronic inflammatory conditions, consuming any antioxidant supplements or anti-inflammatory medicines. Pregnancy or lactation or expecting to get pregnant during the study. Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data. Cancer patients. Anyone having hypersensitivity to N-acetylcysteine. Anyone already taking N-acetylcysteine.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1, NAC group<br>Group 1, NAC group (n=30): Patients will receive conventional therapy for diabetic neuropathy in addition to High Dose N-acetyl cysteine (2400 mg/day divided into two doses) daily for 3 months | Drug: Acetyl cysteine<br>* 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<br>* Other names: N-acetyl cysteine;|
| No Intervention: Group 2, Control group<br>Group 2, Control group (n= 30): Patients will receive conventional therapy for diabetic neuropathy alone for 3 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Human Nuclear factor erythroid 2-related factor (NRF2) | Inflammatory marker | change from baseline Human Nuclear factor erythroid 2-related factor at 3 months | 
| Concentration of Tumor necrosis factor alpha | Inflammatory marker | Change from baseline tumor necrosis factor alpha at 3 months | 
| Concentration of Glutathione peroxidase | Oxidative stress markers | Change from baseline glutathione peroxidase at 3 months |