Insulin ResistanceNCT05215821
Insulin Resistance and Severity of Coronary Artery Disease
An observational study of Insulin Resistance, run by Sohag University at 1 site in Egypt.
Trial summary
this is an observertional study aimed at Study the association between Insulin resistance estimated by HOMA and Angiographic Severity of Coronary Artery Disease in Non Diabetic \& Non Obese Patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 28 Feb 2022
- How long will I take part?
- 2 Days
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients undergoing coronary angiography due to suspected coronary artery disease
Who may be able to join
- patients undergoing coronary angiography (CA) for ACS or stable angina in the Catheterization Laboratory of internal Medicine department and El Noor specialized cardiac center at the study period.
Who cannot join
- age < 18 years,
- pregnancy or breastfeeding,
- BMI >30 Kg/m2 and
- presence of pre-diabetes or overt diabetes.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag uniersity hosoital
Sohag
Ali mo Altaher, lecturer, 01003376529, dr.ali.altaher30@gmail.com
About this study
Official title: HOMA Estimated Insulin Resistance as a Marker for Angiographic Severity of Coronary Artery Disease in Non Diabetic & Non Obese Patients.
this is an observertional study aimed at Study the association between Insulin resistance estimated by HOMA and Angiographic Severity of Coronary Artery Disease in Non Diabetic \& Non Obese Patients.
- Conditions
- Insulin Resistance
- Medical subject headings
- Insulin Resistance
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 |
|---|---|---|
| group1 | subjects with evidence of insulin resistance estimated by high HOMA level | |
| group 2 | subjects without insulin resistance estimated by normal HOMA level |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA IR level estimated by Two-site immunoenzymometric assay
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Feb 2021
- Primary completion30 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ahmed Altaher, Sohag University
- Investigators
- Ali mo Altaher, lecturer, Principal investigator, Sohag faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215821
- Sponsor's protocol ID
- Soh-Med-22-01-42
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- 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 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOMA Estimated Insulin Resistance as a Marker for Angiographic Severity of Coronary Artery Disease in Non Diabetic & Non Obese Patients.
- ClinicalTrials.gov ID
- NCT05215821
- Acronym / sponsor ID
- Soh-Med-22-01-42
- Conditions
- Insulin Resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 31 Jan 2022 (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.
this is an observertional study aimed at Study the association between Insulin resistance estimated by HOMA and Angiographic Severity of Coronary Artery Disease in Non Diabetic \& Non Obese Patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group1 | – | –subjects with evidence of insulin resistance estimated by high HOMA level |
| group 2 | – | –subjects without insulin resistance estimated by normal HOMA level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing coronary angiography due to suspected coronary artery disease
Key inclusion criteria (1 listed)
- patients undergoing coronary angiography (CA) for ACS or stable angina in the Catheterization Laboratory of internal Medicine department and El Noor specialized cardiac center at the study period.
Key exclusion criteria (4 listed)
- age < 18 years,
- pregnancy or breastfeeding,
- BMI >30 Kg/m2 and
- presence of pre-diabetes or overt diabetes.
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
HOMA IR level estimated by Two-site immunoenzymometric assay
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- 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.
Ali mo Altaher, lecturer principal investigator
Sohag faculty of medicine
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 Insulin Resistance, run by Sohag 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 4 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: status not confirmed, as of the sponsor's last update on 31 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali mo Altaher, lecturer (01003376529 ext. +20, dr.ali.altaher30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA IR level estimated by Two-site immunoenzymometric assay (time frame: 4 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 31 Jan 2022.