Adipokine Genetic Variations in predictingNAFLD Progressi... | NCT04561895

Studies
Adipokine Genetic Variations in predictingNAFLD Progression to NASH in Egyptian Patients

NCT04561895

Sponsor

Cairo University

Status

Completed

Last Update Posted

Sep 24, 2020Actual

Enrollment

224Actual

Phase

Not provided

Conditions

NAFLD
NASH - Nonalcoholic Steatohepatitis

Interventions

DNA extraction

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

Sep 2020

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

Jan 1, 2020Actual

Primary Completion Date

Sep 15, 2020Actual

Completion Date

Sep 16, 2020Actual

First Submitted Date

Sep 18, 2020

First Submission Date that Met QC Criteria

Sep 18, 2020

First Posted Date

Sep 24, 2020Actual

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

Sep 18, 2020

Last Update Posted Date

Sep 24, 2020Actual

Name	Class
El-Sahel Teaching Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

224Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group		healthy volunteers with absence of NAFLD	Genetic: DNA extraction
test group		patients with confirmed NAFLD diagnosis	Genetic: DNA extraction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DNA extraction	Genetic	investigation of DNA polymorphism in patients suffering from NAFLD	control group test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Egyptian patients confirmed NAFLD diagnosis diabetic

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

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

Egyptian diabetic patients diagnosed with NAFLD

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amal Ahmed, PhD	professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
El Sahel teaching hospital		Cairo	Shobra	11311	Egypt

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

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided