Effect of High-Dose NAC on Patients With DPN

Phase 4

• Conditions: Diabetic Neuropathies
• Interventions: Drug: Acetyl cysteine

• Registration Number: NCT04766450
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-23
• Study Start: 2021-12-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-08
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1, NAC group	Acetyl cysteine	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Demerdash Hospital; 🇪🇬 Cairo, Egypt