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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.
Patient written informed consent will be taken prior to study conductance
Inflammatory and oxidative stress marker samples will be stored at -80 for further evaluation using ELISA kit at the end of the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Group 2, Control group | No Intervention | Group 2, Control group (n= 30): Patients will receive conventional therapy for diabetic neuropathy alone for 3 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Toronto clinical scoring system |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherien Emara, TA | Contact | 01154089169 | sherienemara@hotmail.com | |
| Sara Farid Mohamed, Lecturer | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Lamia El Wakeel, Professor | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Demerdash Hospital | Recruiting | Cairo | 02 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40038825 | Derived | 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. |
| Label | URL |
|---|---|
| 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. | View source |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Randomized controlled clinical trial
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|
|
Questionnaire. as score increase means symptoms increase
| At baseline and after 3 months |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |