Association of Triglyceride-glucose Index With Cardiac Hemodynamics

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05702112
Collaborator
(none)
100
13

Study Details

Study Description

Brief Summary

  1. To estimate the prevelance of IR in obese patients based on TYG index . 2) To screen early cardiovascular abnormalities in obese asymptomatic patients using conventional echocardiography and electrocardiogram . 3) To detect association of cardiovascular hemodynamics with TyG index . Assess cardiovascular risk in obese patients .
Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Obesity has been a health problem of growing significance all over the world; its prevalence is increasing in both developed and developing countries [1]. According to WHO data, 39% of the global population above 18 years of age are overweight and of these, 13% are obese. Obesity is a chronic (long-term) medical disease. Both overweight (BMI >25 kg/m2) and obesity defined as a ( Body Mass Index, or BMI, of >30 kg/m2) are associated with an increased risk of cardiovascular diseases. This is a consequence on the one hand of obesity itself and on the other hand of associated medical conditions (hypertension, diabetes, insulin resistance ,stroke ,sleep apnea, osteoarthritis, gallstones, high cholesterol, gout, and certain types of cancer ) [2]. Obesity produces a variety of hemodynamic alterations that may cause changes in cardiac morphology which predispose to left and right ventricular dysfunction. Various neurohormonal and metabolic alterations commonly associated with obesity may contribute to these abnormalities of cardiac structure and function [3]. Cardiovascular diseases, including heart failure (HF), atrial fibrillation (AF), and coronary artery disease (CAD), are often associated with obesity. The duration of obesity has a direct impact on the incidence of cardiovascular disease. [4]. The triglyceride-glucose (TyG) index is the logarithmized product of fasting triglycerides and fasting glucose and has been proposed as the alternative indicator of IR ( with sensitivity 96.5 % and specificity 85% ) due to its relevance to lipotoxicity and glucotoxicity compared to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), which is expensive due to insulin measurement [5,6,7] .TyG index has demonstrated a close relationship with cardiometabolic outcomes, namely diabetes, arterial stiffness, hypertension, cardiovascular disease (CVD), stroke and obesity-related cancers in previous studies [8,9].

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Association of Triglyceride-glucose Index With Cardiac Hemodynamics and Cardiovascular Risk Assesment in Obese Patient.
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Apr 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. estimate the prevelance of IR in obese patients based on TYG index . [Baseline]

      The triglyceride-glucose (TyG) index is the logarithmized product of fasting triglycerides and fasting glucose and has been proposed as the alternative indicator of IR ( with sensitivity 96.5 % and specificity 85% ) due to its relevance to lipotoxicity and glucotoxicity compared to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), which is expensive due to insulin measurement

    2. screen early cardiovascular abnormalities in obese asymptomatic patients [Baseline]

      Obesity produces a variety of hemodynamic alterations that may cause changes in cardiac morphology which predispose to left and right ventricular dysfunction. Various neurohormonal and metabolic alterations commonly associated with obesity may contribute to these abnormalities of cardiac structure and function

    Secondary Outcome Measures

    1. detect association of cardiovascular hemodynamics with TyG index . [Baseline]

      TyG index has demonstrated a close relationship with cardiometabolic outcomes, namely diabetes, arterial stiffness, hypertension, cardiovascular disease (CVD), stroke and obesity-related cancers in previous studies.

    2. Assess cardiovascular risk in obese patients . [Baseline]

      Cardiovascular diseases, including heart failure (HF), atrial fibrillation (AF), and coronary artery disease (CAD), are often associated with obesity. The duration of obesity has a direct impact on the incidence of cardiovascular disease.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • The study will include obese patients over two years duration ( Jan 2023 to Jan 2024 )( age above 18 years old ; written consent will be obtained )
    Exclusion Criteria:
    • History of heart failure or patient known to have congenital heart disease, primary or secondary myocardial disease .

    Medications associated with weight gain . Patients with previous cardiac diseases (arrhythmias - valve disease). patients who have recently used glucocorticoids or antipsychotics. Patients on statins .

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Michael Hany, Assistant lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05702112
    Other Study ID Numbers:
    • TyGI in cardiac hemodynamics
    First Posted:
    Jan 27, 2023
    Last Update Posted:
    Jan 27, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michael Hany, Assistant lecturer, Assiut University

    Study Results

    No Results Posted as of Jan 27, 2023