Diabetic Neuropathies
Conditions
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
Interventions
DRUGAcetyl 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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Toronto clinical scoring system | At baseline and after 3 months | Questionnaire. as score increase means symptoms increase |
Countries
Egypt
Contacts
Primary ContactSherien Emara, TA
Backup ContactSara Farid Mohamed, Lecturer
Outcome results
None listed