Insulin ResistanceNCT06237244
Insulin Resistance Indices and Coronary Artery Disease
An observational study of Insulin Resistance and Coronary Artery Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
In this retrospective study from professor Kojuri clinic registry, total number of 1017 patients with first angiography were included and all data were recorded from registry. Insulin resistance was calculated using laboratory data Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin Resistance, Coronary Artery Disease
- What is being tested?
- triglyceride to glucose ratio and triglycerdie to HDL ratio
- How many people
- 1,017 participants
- Where
- 1 siteIran
- Study dates
- 1 Dec 2018to 1 Sep 2023
- How long will I take part?
- 3 Years
- 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
- Adult, Older adult
Study population: Patients more than 18 years old referred for evaluation of coronary artery disease for their first time
Who may be able to join
- patients with age more than 18 years and having undergone coronary angiography
Who cannot join
- incomplete data
- history of prior coronary angiography or revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG))
- serum creatinine \> 1.4 mg/dL
- history of chronic kidney disease (CKD)
- cancer,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting the Presence and Severity of Coronary Artery Disease Using Surrogate Markers of Insulin Resistance: A Cross-Sectional Study
In this retrospective study from professor Kojuri clinic registry, total number of 1017 patients with first angiography were included and all data were recorded from registry. Insulin resistance was calculated using laboratory data
Read the detailed description
This was an analytical cross-sectional retrospective study involving patients with suspected CAD who underwent coronary angiography between December 2018 and May 2023. The information was obtained from patients referred to the outpatient cardiovascular clinic (Professor Kojuri Cardiology Clinic, Shiraz, Iran, www.kojuriclinic.com). Data was extracted from Professor Kojuri Cardiology Clinic database, including patient's information about the clinical history, presence or absence of specific diseases, angiography/angioplasty results, medications, and laboratory values.
A total of 14,708 patients who had undergone coronary angiography at least once were examined. After applying exclusion criteria, 1017 eligible cases were selected for data analysis.
The following data was recorded for the included patients: demographic data, past medical history (such as DM, hypertension, etc.), systolic and diastolic blood pressure, weight and height, fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and serum creatinine (Cr). Body mass index (BMI) was calculated as weight (Kg) divided by the square of height (m2). Obesity was defined as BMI ≥ 30 Kg/m2.
Laboratory values were selected from the time before angiography, and if not available, from the time shortly after the angiography. This helped us find those values which could best represent the metabolic state of patients at the time of angiography, while reducing the confounding effect of statin use.
- Conditions
- Insulin Resistance, Coronary Artery Disease
- Being tested
- triglyceride to glucose ratio, triglycerdie to HDL ratio
- Keywords
- coronary artery disease, insulin resistance, triglyceride glucose index
- Medical subject headings
- Insulin Resistance, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triglyceride to glucose ratioDiagnostic test
Ratio of triglyceride level to glucose
triglycerdie to HDL ratioDiagnostic test
Ratio of triglyceride to HDL cholesterol
| Study group | Role | What they receive |
|---|---|---|
| coronary artery disease | patients with coronary angiography of at least one vessel with more than 50% stenosis Receives: Diagnostic Test: triglyceride to glucose ratio; Diagnostic Test: triglycerdie to HDL ratio | |
| no coronary artery disease | patient with no stenosis in coronary angiography Receives: Diagnostic Test: triglyceride to glucose ratio; Diagnostic Test: triglycerdie to HDL ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance index: level of triglyceride to glucose ratio from blood sample
correlation of coronary artery disease and triglyceride glucose ratio in blood laboratory tests
Measured: 3 years
insulin resistance index: Level of triglyceride to HDL ratio from blood sample
correlation of coronary artery disease and triglyceride to HDL level ratio in blood laboratory sample
Measured: 3 years
Secondary outcomes (1)
metabolic syndrome
metabolic syndrome based on criteria of metabolic syndrome
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Dec 2018
- Primary completion1 May 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,017 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
- Investigators
- Javad Kojuri, MD. MS., Principal investigator, Professor kojuri cardiology clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237244
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1402.252
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available based on rational request
Publications
Jahangiri S, Mosalamiaghili SA, Heydarzadeh R, Yousefzadeh M, Golchin Vafa R, Zarifkar H, Assadian K, Sohrabizadeh S, Zarifkar H, Sadeghi M, Hosseini N, Montaseri M, Hosseini SA, Kojuri J. Predicting the presence and severity of coronary artery disease using surrogate markers of insulin resistance: A cross-sectional study. ARYA Atheroscler. 2025;21(1):44-53. doi: 10.48305/arya.2025.42573.2960.
PubMed 40401209
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Presence and Severity of Coronary Artery Disease Using Surrogate Markers of Insulin Resistance: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06237244
- Acronym / sponsor ID
- IR.SUMS.MED.REC.1402.252
- Conditions
- Insulin Resistance, Coronary Artery Disease
- Keywords
- coronary artery disease, insulin resistance, triglyceride glucose index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 1 Feb 2024 (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.
In this retrospective study from professor Kojuri clinic registry, total number of 1017 patients with first angiography were included and all data were recorded from registry. Insulin resistance was calculated using laboratory data
Detailed description
This was an analytical cross-sectional retrospective study involving patients with suspected CAD who underwent coronary angiography between December 2018 and May 2023. The information was obtained from patients referred to the outpatient cardiovascular clinic (Professor Kojuri Cardiology Clinic, Shiraz, Iran, www.kojuriclinic.com). Data was extracted from Professor Kojuri Cardiology Clinic database, including patient's information about the clinical history, presence or absence of specific diseases, angiography/angioplasty results, medications, and laboratory values.
A total of 14,708 patients who had undergone coronary angiography at least once were examined. After applying exclusion criteria, 1017 eligible cases were selected for data analysis.
The following data was recorded for the included patients: demographic data, past medical history (such as DM, hypertension, etc.), systolic and diastolic blood pressure, weight and height, fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and serum creatinine (Cr). Body mass index (BMI) was calculated as weight (Kg) divided by the square of height (m2). Obesity was defined as BMI ≥ 30 Kg/m2.
Laboratory values were selected from the time before angiography, and if not available, from the time shortly after the angiography. This helped us find those values which could best represent the metabolic state of patients at the time of angiography, while reducing the confounding effect of statin use.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coronary artery disease | – | Diagnostic Test: triglyceride to glucose ratio, Diagnostic Test: triglycerdie to HDL ratiopatients with coronary angiography of at least one vessel with more than 50% stenosis |
| no coronary artery disease | – | Diagnostic Test: triglyceride to glucose ratio, Diagnostic Test: triglycerdie to HDL ratiopatient with no stenosis in coronary angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients more than 18 years old referred for evaluation of coronary artery disease for their first time
Key inclusion criteria (1 listed)
- patients with age more than 18 years and having undergone coronary angiography
Key exclusion criteria (5 listed)
- incomplete data
- history of prior coronary angiography or revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG))
- serum creatinine \> 1.4 mg/dL
- history of chronic kidney disease (CKD)
- cancer,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triglyceride to glucose ratioRatio of triglyceride level to glucose | Diagnostic test | coronary artery disease, no coronary artery disease |
| triglycerdie to HDL ratioRatio of triglyceride to HDL cholesterol | Diagnostic test | coronary artery disease, no coronary artery disease |
Primary outcome
insulin resistance index: level of triglyceride to glucose ratio from blood sample
Time frame: 3 years
correlation of coronary artery disease and triglyceride glucose ratio in blood laboratory tests
insulin resistance index: Level of triglyceride to HDL ratio from blood sample
Time frame: 3 years
correlation of coronary artery disease and triglyceride to HDL level ratio in blood laboratory sample
1 secondary outcome
metabolic syndrome
Time frame: 3 years
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 5 Feb 2024.
- Derived from this study: PubMed 40401209Jahangiri S, Mosalamiaghili SA, Heydarzadeh R, Yousefzadeh M, Golchin Vafa R, Zarifkar H, Assadian K, Sohrabizadeh S, Zarifkar H, Sadeghi M, Hosseini N, Montaseri M, Hosseini SA, Kojuri J. Predicting the presence and severity of coronary artery disease using surrogate markers of insulin resistance: A cross-sectional study. ARYA Atheroscler. 2025;21(1):44-53. doi: 10.48305/arya.2025.42573.2960.
- Individual participant dataSharing planned: No. Data are available based on rational request
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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.
Javad Kojuri, MD. MS. principal investigator
Professor kojuri cardiology clinic
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 and Coronary Artery Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 5 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 5 Feb 2024. 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 Iran. 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?
insulin resistance index: level of triglyceride to glucose ratio from blood sample (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06237244, which also lists 1 linked publication.
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 5 Feb 2024.