Dyslipidemia Associated With Type II Diabetes MellitusNCT07362953
Paraclinical Cardiometabolic Risk Assessment in Type 2 Diabetes
An observational study of Dyslipidemia Associated With Type II Diabetes Mellitus, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyslipidemia Associated With Type II Diabetes Mellitus
- How many people
- 2,188 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 15 Dec 2025
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Having a diagnosis of T2DM
- Having a diagnosis of prediabetes
- Being between 18 and 65 years of age.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpaşa University Health Research and Application Hospital
Tokat Province, 60250
About this study
Official title: 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.
Read the 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.
- Keywords
- Type 2 Diabetes, Metabolic-inflammatory indices
- Medical subject headings
- Diabetes Mellitus, Type 2
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 |
|---|---|---|
| Type 2 Diabetes Mellitus Group | Participants diagnosed with Type 2 Diabetes Mellitus who were included for baseline data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure Title: Triglyceride-glucose index (TyG indice)
TyG index: ln [fasting triglycerides (mg/dL) × fasting glucose (mg/dL)] / 2
Measured: 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)]
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Mar 2025
- Primary completion15 Nov 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyslipidemia Associated With Type II Diabetes MellitusStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,188 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Azize Özşahin Delibaş, Tokat Gaziosmanpasa University
- Investigators
- Elif A Delibaş, Principal investigator, Tokat Gaziosmanpaşa Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362953
- Sponsor's protocol ID
- 25-MOBAEK-042
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraclinical Assessment of Cardiometabolic Risk Based on Novel Biochemical İndices in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07362953
- Acronym / sponsor ID
- 25-MOBAEK-042
- Keywords
- Type 2 Diabetes, Metabolic-inflammatory indices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,188 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 23 Jan 2026 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Mellitus Group | – | –Participants diagnosed with Type 2 Diabetes Mellitus who were included for baseline data collection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Having a diagnosis of T2DM
- Having a diagnosis of prediabetes
- Being between 18 and 65 years of age.
Key exclusion criteria (6 listed)
- Having any other chronic disease accompanying T2DM/prediabetes
- Receiving hormone therapy
- Using lipid-lowering agents
- Being pregnant/breastfeeding
- Having an acute infection
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
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
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)]
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
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 23 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Elif A Delibaş principal investigator
Tokat Gaziosmanpaşa Üniversitesi
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 Dyslipidemia Associated With Type II Diabetes Mellitus, run by Tokat Gaziosmanpasa University 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 3 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 23 Jan 2026. 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?
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.). The study lists 3 primary outcomes in all. 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 23 Jan 2026.