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NCT Number: NCT07362953

Paraclinical Cardiometabolic Risk Assessment in Type 2 Diabetes

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by impaired insulin action and increased cardiometabolic risk. Visceral adiposity, insulin resistance, systemic inflammation, and dyslipidemia play key roles in the development of cardiovascular disease in individuals with T2DM. In this context, simple, rapid, and cost-effective biomarkers are increasingly important for risk assessment. The triglyceride-glucose (TyG) index is a practical indicator of insulin resistance, while the Atherogenic Plasma Index (API) reflects cardiovascular risk related to dyslipidemia. The Systemic Immune Inflammation Index (SII), derived from routine blood counts, serves as a marker of systemic inflammation. This study aims to evaluate the predictive value of TyG, API, and SII in assessing insulin resistance, cardiometabolic risk, and inflammation in patients with T2DM, thereby supporting early diagnosis and improved clinical management.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokat Gaziosmanpaşa University Health Research and Application Hospital

Tokat Province, 60250, Turkey (Türkiye)

About this study

Diabetes mellitus (DM) is a chronic metabolic disorder characterized by the inability to adequately utilize essential nutrients, including carbohydrates, fats, and proteins, as a result of insulin deficiency and/or impaired insulin action. In individuals with type 2 diabetes mellitus (T2DM), comprehensive assessment of cardiovascular disease risk factors and visceral adiposity is of critical importance. Excess visceral fat is closely associated with increased insulin resistance and an elevated risk of cardiovascular disease, reflecting the well-established relationship between cardiometabolic disorders and adiposity. Moreover, excessive body fat accumulation contributes to a chronic low-grade systemic inflammatory state, which plays a central role in the pathogenesis of metabolic syndrome. When metabolic syndrome coexists with dyslipidemia, the risk of cardiovascular disease is further amplified.

In this context, the availability of biomarkers that are easy to apply, rapidly measurable, and cost-effective is of considerable clinical relevance. The triglyceride-glucose (TyG) index has emerged as a practical and reliable parameter for the assessment of insulin resistance. This index is calculated using fasting plasma triglyceride and glucose concentrations, which are routinely measured and widely accessible laboratory parameters. The TyG index provides valuable insight into metabolic disturbances related to insulin resistance and its potential association with cardiovascular disease. The Systemic Immune Inflammation Index (SII) is another emerging biomarker derived from peripheral blood cell counts, calculated using lymphocyte (L), platelet (P), and neutrophil (N) values, and reflects the balance between inflammatory and immune responses. In addition, the Atherogenic Plasma Index (API) serves as an indicator of atherogenic dyslipidemia and may offer information regarding the severity of insulin resistance associated with impaired glucose metabolism, as well as its relationship with cardiovascular risk.

The aim of this study is to evaluate the TyG index as a predictor of insulin resistance, the API as a marker of cardiovascular risk, and the SII as a significant indicator of systemic inflammation in patients diagnosed with T2DM. These novel biochemical indices may facilitate early risk stratification, improve treatment planning, and ultimately contribute to more effective clinical management of individuals with T2DM.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having a diagnosis of T2DM
  • Having a diagnosis of prediabetes
  • Being between 18 and 65 years of age.

Exclusion criteria

  • Having any other chronic disease accompanying T2DM/prediabetes
  • Receiving hormone therapy
  • Using lipid-lowering agents
  • Being pregnant/breastfeeding
  • Having an acute infection
  • Having any malignant/inflammatory disease

Treatment and study plan

Primary outcomes

  1. Outcome Measure Title: Triglyceride-glucose index (TyG indice)

    Time frame: Description: Calculated using fasting glucose and triglyceride levels. Time Frame: At baseline Unit of Measure: Index value Calculated from hematological and biochemical results obtained by trained staff.

    TyG index: ln [fasting triglycerides (mg/dL) × fasting glucose (mg/dL)] / 2

  2. Outcome Measure Title: Atherogenic Plasma Index (API)

    Time frame: Description: Calculated using HDL-cholesterol and triglycerides levels. Time Frame: At baseline Unit of Measure: Index value Calculated from hematological and biochemical results obtained by trained staff.

    API: log [triglycerides (mg/dL) / HDL-cholesterol (mg/dL)]

  3. Outcome Measure Title: Systemic Immuno-Inflammation Index (SII)

    Time frame: Description: Calculated using platelet count, neutrophil count, lymphocyte count. Time Frame: At baseline Unit of Measure: Index value Calculated from hematological and biochemical results obtained by trained staff.

    SII = Platelet count x Neutrophil count / Lymphocyte count

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

Paraclinical Assessment of Cardiometabolic Risk Based on Novel Biochemical İndices in Type 2 Diabetes

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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