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Comparison Between Different Insulin Resistance Markers and Their Correlation With Severity of Coronary Artery Disease in Non-diabetic Patients.

5. november 2026 oppdatert av: Ahmed Mostafa Ahmed Mostafa, Sohag University

This study aims to investigate the association between insulin resistance (IR) and coronary artery disease (CAD) in non-diabetic patients. Furthermore, it evaluates the predictive value of multiple insulin resistance indices - specifically, the homeostatic model assessment for insulin resistance (HOMA-IR), Metabolic score for insulin resistance (METS-IR), Triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio, and triglyceride and glucose (TyG) index, as non-invasive markers of coronary artery disease severity. The diagnostic performance of these indices will be compared among patients with suspected CAD undergoing coronary angiography at the cardiac catheterization unit at Sohag University Hospital.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Antatt)

60

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

      • Sohag, Egypt, 82511

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

patients indicated for coronary angiography in sohag university hospital

Beskrivelse

Inclusion Criteria:

  • Aged ≥18 year.
  • Both sexes
  • Non-diabetic patients based on glycosylated hemoglobin (HbA1c) .
  • Patient with Ischemic heart disease indicated for coronary angiography.

Exclusion Criteria:

  • Patients age less than 18 years old.
  • Insulin dependent diabetes
  • Pregnant women
  • End-stage renal disease on dialysis.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: CROSS_SECTIONAL

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
group 1 patients indicated for coronary angiography

evaluates the predictive value of multiple insulin resistance indices - specifically, the homeostatic model assessment for insulin resistance (HOMA-IR), Metabolic score for insulin resistance (METS-IR), Triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio, and triglyceride and glucose (TyG) index, as non-invasive markers of coronary artery disease severity.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Association between Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Tidsramme: baseline, before coronary angiography, within the 2-hour assessment period.

Insulin resistance will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated as fasting plasma glucose and fasting insulin levels according to the following formula: HOMA-IR = [FPG (mg/dL) x fasting insulin (microU/mL)] / 405.

Results will be reported as a continuous, dimensionless index; higher values indicate greater insulin resistance.

The association between HOMA-IR and coronary artery disease severity will be evaluated using coronary angiographic findings, including SYNTAX score and TIMI flow grade.

baseline, before coronary angiography, within the 2-hour assessment period.
Association between Metabolic Score for Insulin Resistance (METS-IR) and coronary artery disease severity.
Tidsramme: baseline, prior coronary angiography, within the 2-hour assessment period.

METS-IR will be calculated according to the following formula: Ln[(2 × fasting plasma glucose (mg/dL)) + fasting triglycerides (mg/dL)] × body mass index (kg/m²) ÷ Ln[HDL-cholesterol (mg/dL)]. Biochemical parameters will be derived from fasting venous blood collected before coronary angiography. Higher scores indicate greater insulin resistance.

The association between METS-IR and coronary artery disease severity will be evaluated using coronary angiographic findings, including SYNTAX score and TIMI flow grade.

baseline, prior coronary angiography, within the 2-hour assessment period.
Association between Triglyceride-Glucose (TyG) Index and coronary artery disease severity.
Tidsramme: baseline, prior coronary angiography, within the 2-hour assessment period.

The TyG index will be calculated according to the following formula: Ln[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL) ÷ 2], using blood samples collected before coronary angiography. The index is dimensionless and serves as a surrogate marker of insulin resistance, with higher values indicating greater resistance.

The association between TyG index and coronary artery disease severity will be evaluated using coronary angiographic findings, including SYNTAX score and TIMI flow grade.

baseline, prior coronary angiography, within the 2-hour assessment period.
Association between Triglyceride to High-Density Lipoprotein Cholesterol Ratio (TG/HDL-C) and coronary artery disease severity.
Tidsramme: Within 2 hours before coronary angiography

The TG/HDL-C ratio will be calculated according to the following formula: fasting serum triglycerides (mg/dL) divided by fasting serum HDL-cholesterol (mg/dL), using blood samples collected before coronary angiography. The ratio is dimensionless and serves as a surrogate marker of insulin resistance, with higher values indicating greater resistance.

The association between TG/HDL-C ratio and coronary artery disease severity will be evaluated using coronary angiographic findings, including SYNTAX score and TIMI flow grade.

Within 2 hours before coronary angiography
Assessment of coronary artery disease severity and anatomical complexity using SYNTAX score.
Tidsramme: During coronary angiography

The anatomical complexity and severity of coronary artery disease will be assessed using the SYNTAX score calculated from coronary angiographic images. The SYNTAX score will be calculated based on the number, location, and anatomical characteristics of coronary lesions with diameter stenosis of at least 50% in coronary vessels with a reference diameter of at least 1.5 mm. The total numerical score will be reported; higher scores indicate greater anatomical complexity. Categories are low (≤22), intermediate (23-32), and high (≥33).

The relationship between SYNTAX score and the four insulin resistance markers (HOMA-IR, METS-IR, TyG index, and TG/HDL-C ratio) will be evaluated.

During coronary angiography

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of coronary blood flow using TIMI flow grade.
Tidsramme: During coronary angiography

Coronary blood flow in all major coronary arteries will be assessed during coronary angiography using the Thrombolysis in Myocardial Infarction (TIMI) flow grading system. Coronary blood flow will be classified into four grades:

  • TIMI Grade 0: No antegrade flow.
  • TIMI Grade 1: Penetration without distal perfusion.
  • TIMI Grade 2: Partial perfusion with delayed flow.
  • TIMI Grade 3: Complete perfusion. The association between insulin resistance markers and TIMI flow grade will be evaluated
During coronary angiography

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

22. oktober 2026

Først innsendt som oppfylte QC-kriteriene

5. november 2026

Først lagt ut (Faktiske)

10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

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UBESLUTTE

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