Simple Steatosis Non Fatty LiverPhase 3NCT05589584
N-acetyl Cysteine and Patients with Non-alcoholic Fatty Liver Disease
A Phase 3 study testing N acetyl cysteine with weight reduction in people with Simple Steatosis Non Fatty Liver, run by Ain Shams University at 1 site in Egypt.
Trial summary
Effect of N-acetyl cysteine on markers of oxidative stress and insulin resistance in patients with Non-alcoholic fatty liver disease Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Simple Steatosis Non Fatty Liver
- What is being tested?
- N acetyl cysteine with weight reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Aug 2024
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females aged 18-60 years diagnosed with NAFLD
Who cannot join
- History of alcohol consumption, drug addiction or the use of medications known to precipitate steatohepatitis.
- Patients with schistosomiasis, active hepatitis B or C, autoimmune and diabetes mellitus.
- current Consumption of any antioxidant supplements and hepatotoxic drug.
- 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.
- Active Cancer patients.
- Anyone having hypersensitivity to N-acetylcysteine.
- Anyone already taking N-acetylcysteine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of N-acetyl Cysteine on Markers of Oxidative Stress and Insulin Resistance in Patients with Non-alcoholic Fatty Liver Disease
Effect of N-acetyl cysteine on markers of oxidative stress and insulin resistance in patients with Non-alcoholic fatty liver disease
- Conditions
- Simple Steatosis Non Fatty Liver
- Being tested
- N acetyl cysteine with weight reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N acetyl cysteine with weight reductionDrug
high dose 2400mg/day
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | NAC and weight reduction program Receives: Drug: N acetyl cysteine with weight reduction |
| control | No intervention | weight reduction program only |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the effect of NAC on leptin
leptin as insulin resistance marker in NAFLD
Measured: 3 months
Secondary outcomes (1)
assessment of the effect of NAC on MDA
MDA as oxidative stress marker in NAFLD
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Nov 2022
- Primary completion20 May 2024
- Study completion1 Aug 2024
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 Simple Steatosis Non Fatty LiverStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohammad Ramadan, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589584
- Sponsor's protocol ID
- 1234867
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramadan AM, El-Wakeel LM, Adel A, Abdel-Wahab M, Fahmy SF. Effect of high dose N-acetyl cysteine supplementation on markers of oxidative stress and insulin resistance in non-diabetic patients with metabolic dysfunction associated steatotic liver disease: a randomized controlled trial. BMC Gastroenterol. 2026 Aug 12;26(1):500. doi: 10.1186/s12876-026-05157-x.
PubMed 42587287
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-acetyl Cysteine on Markers of Oxidative Stress and Insulin Resistance in Patients with Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05589584
- Acronym / sponsor ID
- 1234867
- Conditions
- Simple Steatosis Non Fatty Liver
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 21 Oct 2022 (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.
Effect of N-acetyl cysteine on markers of oxidative stress and insulin resistance in patients with Non-alcoholic fatty liver disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Drug: N acetyl cysteine with weight reductionNAC and weight reduction program |
| control | No intervention | –weight reduction program only |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males or females aged 18-60 years diagnosed with NAFLD
Key exclusion criteria (8 listed)
- History of alcohol consumption, drug addiction or the use of medications known to precipitate steatohepatitis.
- Patients with schistosomiasis, active hepatitis B or C, autoimmune and diabetes mellitus.
- current Consumption of any antioxidant supplements and hepatotoxic drug.
- 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.
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 |
|---|---|---|
| N acetyl cysteine with weight reductionhigh dose 2400mg/day | Drug | intervention |
Primary outcome
assessment of the effect of NAC on leptin
Time frame: 3 months
leptin as insulin resistance marker in NAFLD
1 secondary outcome
assessment of the effect of NAC on MDA
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Derived from this study: PubMed 42587287Ramadan AM, El-Wakeel LM, Adel A, Abdel-Wahab M, Fahmy SF. Effect of high dose N-acetyl cysteine supplementation on markers of oxidative stress and insulin resistance in non-diabetic patients with metabolic dysfunction associated steatotic liver disease: a randomized controlled trial. BMC Gastroenterol. 2026 Aug 12;26(1):500. doi: 10.1186/s12876-026-05157-x.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N acetyl cysteine with weight reduction in people with Simple Steatosis Non Fatty Liver, 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 17 Oct 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the effect of NAC on leptin (time frame: 3 months). 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 NCT05589584, 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 17 Oct 2024.