Effect of High-Dose NAC on Patients With DPN

Diabetic Neuropathies Clinical Trial

— NAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766450
• Other study ID #: NAC in DPN
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2022
• Source: Ain Shams University
• Contact: Sherien Emara, TA
• Phone: 01154089169
• Email: sherienemara[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies

Intervention

Drug:
• Acetyl cysteine
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-in?ammatory effects via inhibition of NF-?B activation and reducing subsequent cytokine production . Mitochondria-protective mechanisms of NAC may also be related to its anti-oxidant and anti-in?ammatory properties

Locations

Country	Name	City	State
Egypt	Demerdash Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Michigan neuropathy screening instrument.	Questionnaire of 15 yes or no questions. score of 13 or more means more neuropathic symptoms	At baseline and after 3 months
Other	Toronto clinical scoring system	Questionnaire. as score increase means symptoms increase	At baseline and after 3 months
Primary	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
Primary	Concentration of Tumor necrosis factor alpha	Inflammatory marker	Change from baseline tumor necrosis factor alpha at 3 months
Primary	Concentration of Glutathione peroxidase	Oxidative stress markers	Change from baseline glutathione peroxidase at 3 months

External Links

•   Aldini, G., Altomare, A., Baron, G., Vistoli, G., Carini, M., Borsani, L., & Sergio, F. (2018). N-Acetylcysteine as an antioxidant and disulphide breaking agent: the reasons why. Free Radical Research, 52(7), 751-762
•   Berk, M., Malhi, G. S., Gray, L. J., & Dean, O. M. (2013). The promise of N-acetylcysteine in neuropsychiatry. Trends in Pharmacological Sciences, 34(3), 167-177.