Effect of High-Dose NAC on Patients With DPN

• Sponsor: Ain Shams University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04766450
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathies	Drug: Acetyl cysteine	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled clinical trialRandomized controlled clinical trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of High-Dose N-acetyl Cysteine (NAC) on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy (DPN)
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1, NAC group 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; 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; Other Names: N-acetyl cysteine
No Intervention: Group 2, Control group Group 2, Control group (n= 30): Patients will receive conventional therapy for diabetic neuropathy alone for 3 months.

Outcome Measures

Primary Outcome Measures

1. 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

2. Concentration of Tumor necrosis factor alpha [Change from baseline tumor necrosis factor alpha at 3 months]

   Inflammatory marker

3. Concentration of Glutathione peroxidase [Change from baseline glutathione peroxidase at 3 months]

   Oxidative stress markers

Other Outcome Measures

1. Michigan neuropathy screening instrument. [At baseline and after 3 months]

   Questionnaire of 15 yes or no questions. score of 13 or more means more neuropathic symptoms

2. Toronto clinical scoring system [At baseline and after 3 months]

   Questionnaire. as score increase means symptoms increase

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Demerdash Hospital	Cairo		Egypt	02

Sponsors and Collaborators

• Ain Shams University

Investigators

• Study Director: Lamia El Wakeel, Professor, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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.
• 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

Publications

None provided.

• Responsible Party: Sherien Emara, Teaching Assistant, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04766450
• Other Study ID Numbers: NAC in DPN
• First Posted: Feb 23, 2021
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetic Neuropathies; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Aug 8, 2022