NCT04084925

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

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

December 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

September 3, 2019

Last Update Submit

September 10, 2019

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

  • The correlation between HOMA-IF and NAFLD

    Find a statistically significant correlation between HOMA IR and NAFLD in diabetics

    6 months

Study Arms (2)

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \- Diabetes obesity

You may not qualify if:

  • use of alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum university hospital

Al Fayyum, 63514, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Mohammed A Mashaheet, MD

    Faculty of medicine Fayoum university

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of internal medicine-Faculty of medicine -Fayoum university

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 10, 2019

Study Start

December 1, 2017

Primary Completion

June 20, 2018

Study Completion

December 20, 2018

Last Updated

September 12, 2019

Record last verified: 2019-09

Locations

EG(1)