- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05695651
Association of Triglyceride Glucose Index and HOMA IR as Predictors of Vascular Complications of DM Type 2
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sally Mamdoh Nathan Wasilly, master
- Phone Number: 01221553703
- Email: mamdouhsally5@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients were diagnosed with diabetes type 2 According to American Diabetes Association
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of diabetic patients who developed vascular complications.
Time Frame: baseline
|
Percentage of diabetic patients who developed vascular complications.
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sallym
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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