Paraclinical Cardiometabolic Risk Assessment in Type 2 Diabetes

January 22, 2026 updated by: Elif Azize Özşahin Delibaş, Tokat Gaziosmanpasa University

Paraclinical Assessment of Cardiometabolic Risk Based on Novel Biochemical İndices 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

2188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Tokat Province, Turkey (Türkiye), 60250
        • Tokat Gaziosmanpaşa University Health Research and Application Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients with a confirmed diagnosis of type 2 diabetes mellitus or prediabetes attending the Department of Internal Medicine at Tokat Gaziosmanpaşa University Hospital during the study period will constitute the study population. Enrollment will be limited to individuals who meet the eligibility criteria and provide written informed consent.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Type 2 Diabetes Mellitus Group
Participants diagnosed with Type 2 Diabetes Mellitus who were included for baseline data collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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)]
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.
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Investigators

  • Principal Investigator: Elif A Delibaş, Tokat Gaziosmanpaşa Üniversitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

November 15, 2025

Study Completion (Actual)

December 15, 2025

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-MOBAEK-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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