Clinical trial NCT04766450: Effect of High-Dose NAC on Patients With DPN
Official title: Effect of High-Dose N-acetyl Cysteine (NAC) on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy (DPN)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Neuropathies
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of Human Nuclear factor erythroid 2-related factor (NRF2)
timeFrame: change from baseline Human Nuclear factor erythroid 2-related factor at 3 months
measure: Concentration of Tumor necrosis factor alpha
timeFrame: Change from baseline tumor necrosis factor alpha at 3 months
measure: Concentration of Glutathione peroxidase
timeFrame: Change from baseline glutathione peroxidase at 3 months
Secondary outcomes:
Other outcomes:
measure: Michigan neuropathy screening instrument.
timeFrame: At baseline and after 3 months
measure: Toronto clinical scoring system
timeFrame: At baseline and after 3 months
Locations:
city: Cairo
country: Egypt
facility: Demerdash Hospital
Study officials:
affiliation: Ain Shams University
name: Lamia El Wakeel, Professor
role: STUDY_DIRECTOR
References: