Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-31 @ 11:36 AM
Study NCT ID:
NCT04766450
Status:
UNKNOWN
Last Update Posted:
2022-08-08
First Post:
2021-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High-Dose NAC on Patients With DPN
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Effect of High-Dose N-acetyl Cysteine (NAC) on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy (DPN)
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAC
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: