NCT04561895

Brief Summary

Due to the limited data concerning Egyptian population. authors aimed to investigate the differentadipokine gene polymorphism related to non alcoholic fatty liver disease incidence, prognosis and progression to steotosis and also to find different related factors including obesitu, diabetes and liver enzymes level

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

September 18, 2020

Last Update Submit

September 18, 2020

Conditions

NAFLDNASH - Nonalcoholic Steatohepatitis

Keywords

Egyptian populationNAFLDNASHDNA extractionliver enzymes

Outcome Measures

Primary Outcomes (2)

  • investigate adipokine dna polymorphism

    to investigate adipokine gene polymorphism associated with prognosis of NAFLD patients

    1 months

  • correlations

    to correlate between gene polymorphism and glycated hemoglobin, liver enzyme and obesity

    1 month

Study Arms (2)

control group

healthy volunteers with absence of NAFLD

Genetic: DNA extraction

test group

patients with confirmed NAFLD diagnosis

Genetic: DNA extraction

Interventions

DNA extractionGENETIC

investigation of DNA polymorphism in patients suffering from NAFLD

control grouptest group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Egyptian diabetic patients diagnosed with NAFLD

You may qualify if:

  • Egyptian patients confirmed NAFLD diagnosis diabetic

You may not qualify if:

  • Pregnancy and lactation, history of alcohol abuse (as defined by an average daily consumption of alcohol \> 30 g/day in men and \> 20 g/day women), cirrhosis, autoimmune hepatitis and other causes of liver disease (viral hepatitis, hemochromatosis, Wilson's disease), drug induced hepatitis, chronic enteropathies, Chronic kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Sahel teaching hospital

Cairo, Shobra, 11311, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Amal Ahmed, PhD

    professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of pharmacology

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 24, 2020

Study Start

January 1, 2020

Primary Completion

September 15, 2020

Study Completion

September 16, 2020

Last Updated

September 24, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)