N-acetyl Cysteine and Patients with Non-alcoholic Fatty Liver Disease

October 15, 2024 updated by: Asmaa Mohammad Ramadan, Ain Shams University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • NHTMRI

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

14 years and older (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males or females aged 18-60 years diagnosed with NAFLD

Exclusion Criteria:

  • 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.

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
Experimental: intervention
NAC and weight reduction program
Drug: N acetyl cysteine with weight reduction
high dose 2400mg/day
No Intervention: control
weight reduction program only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of the effect of NAC on leptin
Time Frame: 3 months
leptin as insulin resistance marker in NAFLD
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of the effect of NAC on MDA
Time Frame: 3 months
MDA as oxidative stress marker in NAFLD
3 months

Collaborators and Investigators

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

Sponsor

Ain Shams University

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)

November 1, 2022

Primary Completion (Actual)

May 20, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234867

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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