Effect of High-Dose NAC on Patients With DPN

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Diabetic Neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1, NAC group

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 Type ACTIVE_COMPARATOR

Acetyl cysteine

Intervention Type 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

Group 2, Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acetyl 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

Intervention Type DRUG

Other Intervention Names

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N-acetyl cysteine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No