Effect of High-Dose NAC on Patients With DPN

Ain Shams University

Status and phase: Enrolling; Phase 4

Conditions: Diabetic Neuropathies

Treatments: Drug: Acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT04766450

NAC in DPN

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group 1, NAC group

Active Comparator group

Description:

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

Treatment:

Drug: Acetyl cysteine

Group 2, Control group

No Intervention group

Description:

Group 2, Control group (n= 30): Patients will receive conventional therapy for diabetic neuropathy alone for 3 months.