Effect of High-Dose NAC on Patients With DPN (NAC)

August 4, 2022 updated by: Sherien Emara, Ain Shams University

Effect of High-Dose N-acetyl Cysteine (NAC) on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy (DPN)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sara Farid Mohamed, Lecturer

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Recruiting
        • Demerdash Hospital
        • Contact:
          • Mona AbdelSalam, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: 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
Other Names:
  • N-acetyl cysteine
No Intervention: Group 2, Control group
Group 2, Control group (n= 30): Patients will receive conventional therapy for diabetic neuropathy alone for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Human Nuclear factor erythroid 2-related factor (NRF2)
Time Frame: change from baseline Human Nuclear factor erythroid 2-related factor at 3 months
Inflammatory marker
change from baseline Human Nuclear factor erythroid 2-related factor at 3 months
Concentration of Tumor necrosis factor alpha
Time Frame: Change from baseline tumor necrosis factor alpha at 3 months
Inflammatory marker
Change from baseline tumor necrosis factor alpha at 3 months
Concentration of Glutathione peroxidase
Time Frame: Change from baseline glutathione peroxidase at 3 months
Oxidative stress markers
Change from baseline glutathione peroxidase at 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Michigan neuropathy screening instrument.
Time Frame: At baseline and after 3 months
Questionnaire of 15 yes or no questions. score of 13 or more means more neuropathic symptoms
At baseline and after 3 months
Toronto clinical scoring system
Time Frame: At baseline and after 3 months
Questionnaire. as score increase means symptoms increase
At baseline and after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Lamia El Wakeel, Professor, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 13, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAC in DPN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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