Association of Triglyceride Glucose Index and HOMA IR as Predictors of Vascular Complications of DM Type 2

January 20, 2023 updated by: Sally Mamdouh Nathan, Assiut University

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

Not yet recruiting

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

Observational

Enrollment (Anticipated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients were diagnosed with diabetes type 2 According to American Diabetes Association

Description

Inclusion Criteria:

Patients were diagnosed with diabetes type 2 According to American Diabetes Association

Exclusion Criteria:

  1. 18 years or young
  2. Type 1 diabetes or other special types of diabetes
  3. Suffering from acute complications of diabetes, severe chronic complications, or malignant tumors
  4. Patients with a diagnosis of urinary tract infection, renal calculi, or primary renal disease.
  5. Evidence of chronic kidney disease.
  6. Evidence of Diabetic Kidney Disease and/or Diabetic Nephropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 7, 2023

Primary Completion (Anticipated)

January 7, 2025

Study Completion (Anticipated)

March 7, 2025

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Estimate)

January 24, 2023

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe