Type 2 Diabetes MellitusNCT05695651
Association of Triglyceride Glucose Index and HOMA IR as Predictors of Vascular Complications of DM Type 2
An observational study of Type 2 Diabetes Mellitus, run by Assiut University.
Trial summary
Explore the association between Triglyceride glucose index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes. Which shows better performance for assessing insulin resistance Triglyceride glucose index or HOMA-IR in clinical practice regardless of diabetes status Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- triglyceride glucose index and HOMA IR
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 7 Feb 2023to 7 Mar 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were diagnosed with diabetes type 2 According to American Diabetes Association
Who may be able to join
- Patients were diagnosed with diabetes type 2 According to American Diabetes Association
Who cannot join
- 18 years or young
- Type 1 diabetes or other special types of diabetes
- Suffering from acute complications of diabetes, severe chronic complications, or malignant tumors
- Patients with a diagnosis of urinary tract infection, renal calculi, or primary renal disease.
- Evidence of chronic kidney disease.
- Evidence of Diabetic Kidney Disease and/or Diabetic Nephropathy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Association of Triglyceride Glucose Index and HOMA IR as Predictors of Vascular Complications of Type 2 Diabetes Mellitus
- Explore the association between Triglyceride glucose index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes.
- Which shows better performance for assessing insulin resistance Triglyceride glucose index or HOMA-IR in clinical practice regardless of diabetes status
Read the detailed description
Type 2 diabetes mellitus (T2DM) has become a global public health problem. With the improvement of people's living standards and the change of lifestyle, the prevalence of T2DM is increasing year by year.
Insulin resistance (IR) is a manifestation of metabolic abnormalities, also known to be one of the main pathogenic drivers of type 2 diabetes (T2D). The gold standard method to measure insulin resistance is through euglycemic hyperinsulinemic clamp (HIEC). However, it was rarely conducted in clinical settings due to its complex process and high costs. The triglyceride-glucose index (TyG index) is a critical marker, a reliable and straightforward alternative to IR. It based on fasting glucose and triglycerides, it has been proposed as a simple, reliable surrogate measure and less cost-effective for the diagnosis of IR compared with the euglycaemic-hyperinsulinaemic clamp.
It has been shown that TyG index was significantly elevated in patients with T2D and could be used to identify individuals at high risk for early prevention. Increased TyG index can be used with HbA1C to predict complications in diabetic patients.
The homeostasis model assessment for IR (HOMA-IR) is a relatively most widely used tool to assess IR and uses insulin and glucose level derived from the fasting state.
Pathophysiological studies suggest that IR promotes a pro-inflammatory state and dyslipidemia, which may largely be responsible for arterial stiffness progress.
Studies have shown that insulin resistance is a high-risk factor in the occurrence and development of atherosclerosis.
Diabetic macrovascular disease mainly refers to coronary heart disease, cerebrovascular disease, and peripheral artery disease caused by or combined with T2DM, which is the main cause of death and disability of T2DM.
Higher levels of the TyG index were closely related to a greater risk of CKD and microalbuminuria.
concluded that diabetic retinopathy was found increased in patients with insulin resistance.
However, the serum glucose and lipid levels of hospitalized patients with T2D were often relatively high. It is unknown whether TyG index remains a strong risk predictor of diabetes complications in this group of patients with high incidence rate of chronic complications. Chronic hyperglycemia and insulin resistance could lead to vascular damage and are regulated by multiple pathophysiological processes, Therefore, monitoring insulin resistance is of great significance for the prevention and treatment of T2D and its complications.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- triglyceride glucose index and HOMA IR
- 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.
triglyceride glucose index and HOMA IRDiagnostic test
TyG index was calculated as formula: ln[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL)/2].
an insulin resistance score (HOMA-IR) was computed with the formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the association between TyG index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes
Investigate the association between TyG index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes
Measured: baseline
Secondary outcomes (1)
Percentage of diabetic patients who developed vascular complications.
Percentage of diabetic patients who developed vascular complications.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start7 Feb 2023 (estimated)
- Primary completion7 Jan 2025 (estimated)
- Study completion7 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Mamdouh Nathan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695651
- Sponsor's protocol ID
- sallym
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Triglyceride Glucose Index and HOMA IR as Predictors of Vascular Complications of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05695651
- Acronym / sponsor ID
- sallym
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 Feb 2023 (estimated)
- Primary completion
- 7 Jan 2025 (estimated)
- Study completion
- 7 Mar 2025 (estimated)
- First posted
- 25 Jan 2023 (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.
- Explore the association between Triglyceride glucose index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes.
- Which shows better performance for assessing insulin resistance Triglyceride glucose index or HOMA-IR in clinical practice regardless of diabetes status
Detailed description
Type 2 diabetes mellitus (T2DM) has become a global public health problem. With the improvement of people's living standards and the change of lifestyle, the prevalence of T2DM is increasing year by year.
Insulin resistance (IR) is a manifestation of metabolic abnormalities, also known to be one of the main pathogenic drivers of type 2 diabetes (T2D). The gold standard method to measure insulin resistance is through euglycemic hyperinsulinemic clamp (HIEC). However, it was rarely conducted in clinical settings due to its complex process and high costs. The triglyceride-glucose index (TyG index) is a critical marker, a reliable and straightforward alternative to IR. It based on fasting glucose and triglycerides, it has been proposed as a simple, reliable surrogate measure and less cost-effective for the diagnosis of IR compared with the euglycaemic-hyperinsulinaemic clamp.
It has been shown that TyG index was significantly elevated in patients with T2D and could be used to identify individuals at high risk for early prevention. Increased TyG index can be used with HbA1C to predict complications in diabetic patients.
The homeostasis model assessment for IR (HOMA-IR) is a relatively most widely used tool to assess IR and uses insulin and glucose level derived from the fasting state.
Pathophysiological studies suggest that IR promotes a pro-inflammatory state and dyslipidemia, which may largely be responsible for arterial stiffness progress.
Studies have shown that insulin resistance is a high-risk factor in the occurrence and development of atherosclerosis.
Diabetic macrovascular disease mainly refers to coronary heart disease, cerebrovascular disease, and peripheral artery disease caused by or combined with T2DM, which is the main cause of death and disability of T2DM.
Higher levels of the TyG index were closely related to a greater risk of CKD and microalbuminuria.
concluded that diabetic retinopathy was found increased in patients with insulin resistance.
However, the serum glucose and lipid levels of hospitalized patients with T2D were often relatively high. It is unknown whether TyG index remains a strong risk predictor of diabetes complications in this group of patients with high incidence rate of chronic complications. Chronic hyperglycemia and insulin resistance could lead to vascular damage and are regulated by multiple pathophysiological processes, Therefore, monitoring insulin resistance is of great significance for the prevention and treatment of T2D and its complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were diagnosed with diabetes type 2 According to American Diabetes Association
Key inclusion criteria (1 listed)
- Patients were diagnosed with diabetes type 2 According to American Diabetes Association
Key exclusion criteria (6 listed)
- 18 years or young
- Type 1 diabetes or other special types of diabetes
- Suffering from acute complications of diabetes, severe chronic complications, or malignant tumors
- Patients with a diagnosis of urinary tract infection, renal calculi, or primary renal disease.
- Evidence of chronic kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triglyceride glucose index and HOMA IRTyG index was calculated as formula: ln[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL)/2]. an insulin resistance score (HOMA-IR) was computed with the formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance). | Diagnostic test | – |
Primary outcome
Investigate the association between TyG index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes
Time frame: baseline
Investigate the association between TyG index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes
1 secondary outcome
Percentage of diabetic patients who developed vascular complications.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally Mamdoh Nathan Wasilly, master (01221553703, mamdouhsally5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the association between TyG index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes (time frame: baseline). 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 25 Jan 2023.