Insulin ResistanceNCT07260201
Triglyceride-Glucose and TGI-BMI Indices Compared With HOMA-IR
An observational study of Insulin Resistance and Obesity Type 2 Diabetes Mellitus, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity Type 2 Diabetes Mellitus
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 27 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hisar Intercontinental Hospital
Istanbul, Umraniye, 34768
About this study
Official title: Evaluating the Triglyceride-Glucose Index and TGI-BMI for Insulin Resistance Assessment: A Comparative Study With HOMA-IR
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.
Read the detailed description
Insulin resistance (IR) is a central feature of metabolic and cardiovascular disorders, yet the routine measurement of fasting insulin required for HOMA-IR limits its clinical applicability. The triglyceride-glucose index (TGI) and its body mass index-adjusted form (TGI-BMI) have emerged as simple, cost-effective surrogates that rely only on standard biochemical data.
This retrospective study analyzed data from 150 adults evaluated at Hisar Intercontinental Hospital. Participants were categorized into insulin-resistant (HOMA-IR > 2.5) and non-resistant (HOMA-IR < 2.5) groups. Anthropometric and biochemical variables were obtained from medical records. TGI and TGI-BMI values were calculated for each participant, and comparisons were made between groups. Correlation and receiver operating characteristic (ROC) analyses were used to determine the relationship and diagnostic accuracy of these indices relative to HOMA-IR.
The study aims to validate TGI and TGI-BMI as reliable, low-cost indicators of insulin resistance applicable in both clinical and epidemiological settings, especially in laboratories where insulin assays are unavailable. The findings may contribute to improved screening and risk assessment strategies in metabolic disease management.
- Keywords
- Insulin resistance, Triglyceride-glucose index, TGI-BMI, HOMA-IR
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Retrospective data analysis (single time point).
Secondary outcomes (1)
Diagnostic accuracy of the BMI-adjusted Triglyceride-Glucose Index (TGI-BMI)
ROC curve analysis of TGI-BMI compared with HOMA-IR; AUC, sensitivity, specificity values recorded.
Measured: Retrospective data analysis (single time point).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2024
- Primary completion20 Oct 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bekir Sami Uyanık, Hisar Intercontinental Hospital
- Investigators
- Bekir Sami Uyanık, MD, Prof, Principal investigator, Hisar Intercontinental HospitalSelami Aydin, MD, Study director, Hisar Intercontinental HospitalSüleyman İpekci, Prof, Study chair, Hisar Intercontinental Hospital and Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260201
- Sponsor's protocol ID
- HIH 2025 HOMA IR
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Triglyceride-Glucose Index and TGI-BMI for Insulin Resistance Assessment: A Comparative Study With HOMA-IR
- ClinicalTrials.gov ID
- NCT07260201
- Acronym / sponsor ID
- HIH 2025 HOMA IR
- Keywords
- Insulin resistance, Triglyceride-glucose index, TGI-BMI, HOMA-IR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Insulin resistance (IR) is a central feature of metabolic and cardiovascular disorders, yet the routine measurement of fasting insulin required for HOMA-IR limits its clinical applicability. The triglyceride-glucose index (TGI) and its body mass index-adjusted form (TGI-BMI) have emerged as simple, cost-effective surrogates that rely only on standard biochemical data.
This retrospective study analyzed data from 150 adults evaluated at Hisar Intercontinental Hospital. Participants were categorized into insulin-resistant (HOMA-IR > 2.5) and non-resistant (HOMA-IR < 2.5) groups. Anthropometric and biochemical variables were obtained from medical records. TGI and TGI-BMI values were calculated for each participant, and comparisons were made between groups. Correlation and receiver operating characteristic (ROC) analyses were used to determine the relationship and diagnostic accuracy of these indices relative to HOMA-IR.
The study aims to validate TGI and TGI-BMI as reliable, low-cost indicators of insulin resistance applicable in both clinical and epidemiological settings, especially in laboratories where insulin assays are unavailable. The findings may contribute to improved screening and risk assessment strategies in metabolic disease management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients were excluded if they had any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of the Triglyceride-Glucose Index (TGI) for detecting insulin resistance
Time frame: Retrospective data analysis (single time point).
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).
1 secondary outcome
Diagnostic accuracy of the BMI-adjusted Triglyceride-Glucose Index (TGI-BMI)
Time frame: Retrospective data analysis (single time point).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- This publication supports the present study by demonstrating that the triglyceride-glucose (TyG) index is independently associated with an increased risk of diabetes, even among individuals with normal fasting triglyceride and glucose levels. It providesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bekir Sami Uyanık, MD, Prof principal investigator
Hisar Intercontinental Hospital
Selami Aydin, MD study director
Hisar Intercontinental Hospital
Süleyman İpekci, Prof study chair
Hisar Intercontinental Hospital and Atlas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Obesity Type 2 Diabetes Mellitus, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the Triglyceride-Glucose Index (TGI) for detecting insulin resistance (time frame: Retrospective data analysis (single time point).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.