HOMA-IR as a Screening Test in NAFLD | NCT04084925

Studies
HOMA-IR as a Screening Test in NAFLD

NCT04084925

Sponsor

Fayoum University

Status

Completed

Last Update Posted

Sep 12, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

NAFLD

Interventions

Not provided

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 2019

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

Dec 1, 2017Actual

Primary Completion Date

Jun 20, 2018Actual

Completion Date

Dec 20, 2018Actual

First Submitted Date

Sep 3, 2019

First Submission Date that Met QC Criteria

Sep 7, 2019

First Posted Date

Sep 10, 2019Actual

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 10, 2019

Last Update Posted Date

Sep 12, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Abdelkawi Hammad, Lecturer of internal medicine-Faculty of medicine -Fayoum university, Fayoum UniversityPrincipal Investigator

Lead Sponsor

Fayoum UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The aim of this study is to evaluate the role of HOMA-IR in diagnosis of NAFLD in patients with type 2 DM.

Detailed Description

this study is a retrospective cohort study included 100 patients with type 2 DM from the outpatient clinic of internal medicine department at Fayoum University Hospital. They were divided into two equal groups according to the presence of NAFLD by ultrasound. All patients were subjected to history taking, clinical examination and investigations which included: ALT, AST, total cholesterol, TG, FBG and fasting insulin level,HOMA-IR(Homeostatic Model Assessment for Insulin Resistance) assessment.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetics with NAFLD		Diabetics whose abdominal ultrasound showed that they have NAFLD
Diabetics without NAFLD		Diabetics whose abdominal ultrasound showed that they do not have NAFLD

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The correlation between HOMA-IF and NAFLD	Find a statistically significant correlation between HOMA IR and NAFLD in diabetics	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Diabetes obesity

Exclusion Criteria:

use of alcohol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with type 2 diabetes mellitus from the outpatient clinic of internal medicine department at Fayoum University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammed A Mashaheet, MD	Faculty of medicine Fayoum university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fayoum university hospital		Al Fayyum		63514	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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