Diabetic NeuropathiesPhase 4NACNCT04766450
Effect of High-Dose NAC on Patients With DPN
A Phase 4 study testing Acetyl cysteine in people with Diabetic Neuropathies, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Acetyl cysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females aged 18-50 years diagnosed with Type 2 Diabetes taking oral hypoglycemic with controlled at HbA1c (6%-7%.)
- 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).
Who cannot join
- Patients with acute and chronic inflammatory conditions, consuming any antioxidant supplements or anti-inflammatory medicines.
- Pregnancy or lactation or expecting to get pregnant during the study.
- Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data.
- Cancer patients.
- Anyone having hypersensitivity to N-acetylcysteine.
- Anyone already taking N-acetylcysteine.
Trial locations and contacts
1 site in 1 country.
Sara Farid Mohamed, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Demerdash Hospital
Cairo, 02
Mona AbdelSalam, Professor
About this study
Official title: 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.
Read the 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
- Conditions
- Diabetic Neuropathies
- Being tested
- Acetyl cysteine
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl cysteineDrug
Also called N-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
| Study group | Role | What they receive |
|---|---|---|
| Group 1, NAC group | Active comparator | 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 Receives: Drug: Acetyl cysteine |
| Group 2, Control group | No intervention | Group 2, Control group (n= 30): Patients will receive conventional therapy for diabetic neuropathy alone for 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Human Nuclear factor erythroid 2-related factor (NRF2)
Inflammatory marker
Measured: change from baseline Human Nuclear factor erythroid 2-related factor at 3 months
Concentration of Tumor necrosis factor alpha
Inflammatory marker
Measured: Change from baseline tumor necrosis factor alpha at 3 months
Concentration of Glutathione peroxidase
Oxidative stress markers
Measured: Change from baseline glutathione peroxidase at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Dec 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherien Emara, Ain Shams University
- Investigators
- Lamia El Wakeel, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766450
- Sponsor's protocol ID
- NAC in DPN
- Acronym
- NAC
- Status last verified
- Aug 2022
- First submitted
- 13 Feb 2021
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Emara SM, Fahmy SF, AbdelSalam MM, Wakeel LME. Effect of high-dose N-acetyl cysteine on the clinical outcome of patients with diabetic peripheral neuropathy: a randomized controlled study. Diabetol Metab Syndr. 2025 Mar 4;17(1):79. doi: 10.1186/s13098-025-01624-9.
PubMed 40038825
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Dose N-acetyl Cysteine (NAC) on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy (DPN)
- ClinicalTrials.gov ID
- NCT04766450
- Acronym / sponsor ID
- NAC / NAC in DPN
- Conditions
- Diabetic Neuropathies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group 1, NAC group | Active comparator | Drug: Acetyl cysteineGroup 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 2, Control group | No intervention | –Group 2, Control group (n= 30): Patients will receive conventional therapy for diabetic neuropathy alone for 3 months. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males or females aged 18-50 years diagnosed with Type 2 Diabetes taking oral hypoglycemic with controlled at HbA1c (6%-7%.)
- 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).
Key exclusion criteria (6 listed)
- Patients with acute and chronic inflammatory conditions, consuming any antioxidant supplements or anti-inflammatory medicines.
- Pregnancy or lactation or expecting to get pregnant during the study.
- Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data.
- Cancer patients.
- Anyone having hypersensitivity to N-acetylcysteine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyl cysteineAlso: N-acetyl cysteineNAC 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 | Drug | Group 1, NAC group |
Primary outcome
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
Concentration of Tumor necrosis factor alpha
Time frame: Change from baseline tumor necrosis factor alpha at 3 months
Inflammatory marker
Concentration of Glutathione peroxidase
Time frame: Change from baseline glutathione peroxidase at 3 months
Oxidative stress markers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Derived from this study: PubMed 40038825Emara SM, Fahmy SF, AbdelSalam MM, Wakeel LME. Effect of high-dose N-acetyl cysteine on the clinical outcome of patients with diabetic peripheral neuropathy: a randomized controlled study. Diabetol Metab Syndr. 2025 Mar 4;17(1):79. doi: 10.1186/s13098-025-01624-9.
- Berk, M., Malhi, G. S., Gray, L. J., \& Dean, O. M. (2013). The promise of N-acetylcysteine in neuropsychiatry. Trends in Pharmacological Sciences, 34(3), 167-177.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Farid Mohamed, Lecturer contact
Lamia El Wakeel, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetyl cysteine in people with Diabetic Neuropathies, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherien Emara, TA (01154089169, sherienemara@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.