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

• Sponsor: Ain Shams University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05589584
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

Effect of N-acetyl cysteine on markers of oxidative stress and insulin resistance in patients with Non-alcoholic fatty liver disease

Condition or Disease	Intervention/Treatment	Phase
Simple Steatosis Non Fatty Liver	Drug: N acetyl cysteine with weight reduction	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of N-acetyl Cysteine on Markers of Oxidative Stress and Insulin Resistance in Patients With Non-alcoholic Fatty Liver Disease
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. assessment of the effect of NAC on leptin [3 months]

   leptin as insulin resistance marker in NAFLD

Secondary Outcome Measures

1. assessment of the effect of NAC on MDA [3 months]

   MDA as oxidative stress marker in NAFLD

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 metabolic diseases.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NHTMRI	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Asmaa Mohammad Ramadan, hospital pharmacist, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05589584
• Other Study ID Numbers: 1234867
• First Posted: Oct 21, 2022
• Last Update Posted: Oct 21, 2022
• Last Verified: Oct 1, 2022

• 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
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Oct 21, 2022