NCT07362953

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,188

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 8, 2026

Last Update Submit

January 22, 2026

Conditions

Dyslipidemia Associated With Type II Diabetes Mellitus

Keywords

Type 2 DiabetesMetabolic-inflammatory indices

Outcome Measures

Primary Outcomes (3)

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

    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)

    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)

    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.

Study Arms (1)

Type 2 Diabetes Mellitus Group

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpaşa University Health Research and Application Hospital

Tokat Province, 60250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Elif A Delibaş

    Tokat Gaziosmanpaşa Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 23, 2026

Study Start

March 1, 2025

Primary Completion

November 15, 2025

Study Completion

December 15, 2025

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)