NCT07260201

Brief Summary

Insulin resistance plays a key role in the development of type 2 diabetes, metabolic syndrome, and heart disease. The most common way to measure insulin resistance is the HOMA-IR index, but it requires fasting insulin tests, which are not always available in clinical practice. This study aims to assess two simpler and more accessible alternatives: the triglyceride-glucose index (TGI) and its body mass index-adjusted version (TGI-BMI). Data from 150 adult patients were analyzed retrospectively and divided into groups according to their insulin resistance status. Standard laboratory and body measurements were compared between groups, and statistical analyses were used to determine how well TGI and TGI-BMI identify insulin resistance. The results showed that both TGI and TGI-BMI were closely related to insulin resistance and demonstrated high diagnostic accuracy, similar to HOMA-IR. The TGI-BMI index was particularly effective in individuals with obesity. These findings suggest that TGI and TGI-BMI could serve as practical, low-cost alternatives to HOMA-IR for evaluating insulin resistance in clinical and population settings where insulin testing is not routinely available.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

November 18, 2025

Last Update Submit

November 28, 2025

Conditions

Keywords

Insulin resistanceTriglyceride-glucose indexTGI-BMIHOMA-IR

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of the Triglyceride-Glucose Index (TGI) for detecting insulin resistance

    Area under the receiver operating characteristic (ROC) curve (AUC), sensitivity, and specificity of TGI in identifying insulin resistance compared to HOMA-IR (\>2.5 as reference).

    Retrospective data analysis (single time point).

Secondary Outcomes (1)

  • Diagnostic accuracy of the BMI-adjusted Triglyceride-Glucose Index (TGI-BMI)

    Retrospective data analysis (single time point).

Study Arms (2)

Group/Cohort 1 Label: Non-Insulin Resistant (Non-IR) Group

Group 1 - Non-Insulin Resistant (Non-IR) Group Participants with HOMA-IR values below 2.5, classified as non-insulin resistant. Anthropometric and biochemical data (including fasting glucose, triglycerides, and BMI) were analyzed retrospectively to calculate TGI and TGI-BMI indices.

Group/Cohort 2 Label: Insulin Resistant (IR) Group

Group 2 - Insulin Resistant (IR) Group Participants with HOMA-IR values greater than 2.5, classified as insulin resistant. Anthropometric and biochemical measurements were reviewed from medical records, and TGI and TGI-BMI indices were compared with those of the Non-IR group.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent routine biochemical testing and metabolic evaluation at Hisar Intercontinental Hospital. Data were obtained retrospectively from medical records. Participants were divided into two cohorts based on insulin resistance status determined by HOMA-IR values: Non-Insulin Resistant (HOMA-IR \< 2.5) Insulin Resistant (HOMA-IR \> 2.5)

You may qualify if:

  • Eligible participants were adults aged 18-65 years with complete fasting biochemical and anthropometric data. Only patients who were not receiving antidiabetic medications at the time of evaluation were included.

You may not qualify if:

  • Patients were excluded if they had any of the following:
  • Known endocrine disorders (e.g., thyroid dysfunction, Cushing's syndrome)
  • Chronic kidney or liver disease
  • Active infection or systemic inflammatory disease
  • Ongoing use of medications known to affect glucose or lipid metabolism (e.g., corticosteroids, statins, metformin, or insulin)
  • Incomplete or missing laboratory data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hisar Intercontinental Hospital

Istanbul, Umraniye, 34768, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bekir Sami Uyanık, MD, Prof

    Hisar Intercontinental Hospital

    PRINCIPAL INVESTIGATOR
  • Selami Aydin, MD

    Hisar Intercontinental Hospital

    STUDY DIRECTOR
  • Süleyman İpekci, Prof

    Hisar Intercontinental Hospital and Atlas University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Biochemistry, Hisar Intercontinental Hospital

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 3, 2025

Study Start

December 1, 2024

Primary Completion

October 20, 2025

Study Completion

October 27, 2025

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Participant data (PD) and supporting information will be available starting from the date of publication of the study results. The data will remain accessible for a period of 5 years after publication.
Access Criteria
Access to the Individual Participant Data (IPD) and supporting information will be limited to authorized members of the study team and independent researchers who submit a formal request for scientific evaluation. Accessible materials will include the de-identified IPD dataset, study protocol, and relevant analysis outputs
More information

Available IPD Datasets

Individual participant data will not be shared because the study is retrospective and based on anonymized medical records. (no identifier available)Access

Locations