- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04084925
HOMA-IR as a Screening Test in NAFLD
September 10, 2019 updated by: Ahmed Abdelkawi Hammad, Fayoum University
Is HOMA-IR(Homeostatic Model Assessment for Insulin Resistance) a Potential Screening Test for Non-alcoholic Fatty Liver Disease in Adults With Type 2 DM?
The aim of this study is to evaluate the role of HOMA-IR in diagnosis of NAFLD in patients with type 2 DM.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Fayoum, Egypt, 63514
- Fayoum University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with type 2 diabetes mellitus from the outpatient clinic of internal medicine department at Fayoum University Hospital
Description
Inclusion Criteria:
- Diabetes obesity
Exclusion Criteria:
- use of alcohol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The correlation between HOMA-IF and NAFLD
Time Frame: 6 months
|
Find a statistically significant correlation between HOMA IR and NAFLD in diabetics
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mohammed A Mashaheet, MD, Faculty of medicine Fayoum university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Actual)
June 20, 2018
Study Completion (Actual)
December 20, 2018
Study Registration Dates
First Submitted
September 3, 2019
First Submitted That Met QC Criteria
September 7, 2019
First Posted (Actual)
September 10, 2019
Study Record Updates
Last Update Posted (Actual)
September 12, 2019
Last Update Submitted That Met QC Criteria
September 10, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M258
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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