NAFLDNCT04084925
HOMA-IR as a Screening Test in NAFLD
An observational study of NAFLD, run by Fayoum University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the role of HOMA-IR in diagnosis of NAFLD in patients with type 2 DM. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- NAFLD
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 20 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes mellitus from the outpatient clinic of internal medicine department at Fayoum University Hospital
Who may be able to join
- Diabetes obesity
Who cannot join
- use of alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The correlation between HOMA-IF and NAFLD
Find a statistically significant correlation between HOMA IR and NAFLD in diabetics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Dec 2017
- Primary completion20 Jun 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelkawi Hammad, Fayoum University
- Investigators
- Mohammed A Mashaheet, MD, Study director, Faculty of medicine Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084925
- Sponsor's protocol ID
- M258
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT04084925
- Acronym / sponsor ID
- M258
- Conditions
- NAFLD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes mellitus from the outpatient clinic of internal medicine department at Fayoum University Hospital
Key inclusion criteria (1 listed)
- Diabetes obesity
Key exclusion criteria (1 listed)
- use of alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation between HOMA-IF and NAFLD
Time frame: 6 months
Find a statistically significant correlation between HOMA IR and NAFLD in diabetics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed A Mashaheet, MD study director
Faculty of medicine Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between HOMA-IF and NAFLD (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.