Effect of High-Dose NAC on Patients With DPN

NCT04766450 | Unknown Phase 4 DMC

• 1 other identifier: NAC in DPN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (3)

• 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

Other Outcomes (2)

• Michigan neuropathy screening instrument.

  At baseline and after 3 months

• Toronto clinical scoring system

  At baseline and after 3 months

Study Arms (2)

Group 1, NAC group

ACTIVE COMPARATOR

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

Group 2, Control group

NO INTERVENTION

Group 2, Control group (n= 30): Patients will receive conventional therapy for diabetic neuropathy alone for 3 months.

Interventions

Acetyl cysteine DRUG

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

Also known as: N-acetyl cysteine

Group 1, NAC group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Demerdash Hospital

Cairo, 02, Egypt

RECRUITING

Related Publications (1)

• Emara SM, Fahmy SF, AbdelSalam MM, Wakeel LME. Effect of high-dose N-acetyl cysteine on the clinical outcome of patients with diabetic peripheral neuropathy: a randomized controlled study. Diabetol Metab Syndr. 2025 Mar 4;17(1):79. doi: 10.1186/s13098-025-01624-9.

  PMID: 40038825 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Lamia El Wakeel, Professor

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Sherien Emara, TA

CONTACT

01154089169; sherienemara@hotmail.com

Sara Farid Mohamed, Lecturer

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 23, 2021
• Study Start: December 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

EG (1)