N-acetyl Cysteine and Patients with Non-alcoholic Fatty L... | NCT05589584

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

NCT05589584

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Oct 17, 2024Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Simple Steatosis Non Fatty Liver

Interventions

N acetyl cysteine with weight reduction

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Actual

Primary Completion Date

May 20, 2024Actual

Completion Date

Aug 1, 2024Actual

First Submitted Date

Oct 18, 2022

First Submission Date that Met QC Criteria

Oct 18, 2022

First Posted Date

Oct 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2024

Last Update Posted Date

Oct 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental	NAC and weight reduction program	Drug: N acetyl cysteine with weight reduction
control	No Intervention	weight reduction program only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N acetyl cysteine with weight reduction	Drug	high dose 2400mg/day	intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000111	Acetylcysteine

Ancestor Terms

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided