Association of Triglyceride-glucose Index With Cardiac Hemodynamics

Obesity Clinical Trial

Official title:

Association of Triglyceride-glucose Index With Cardiac Hemodynamics and Cardiovascular Risk Assesment in Obese Patient.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05702112
• Other study ID #: TyGI in cardiac hemodynamics
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: April 2024

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Michael Hany Shawky
• Phone: 01009431082
• Email: Michaelhany544[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Description:

Obesity has been a health problem of growing significance all over the world; its prevalence is increasing in both developed and developing countries . 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 ) . 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. 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.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 .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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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Lloyd-Jones DM, Huffman MD, Karmali KN, Sanghavi DM, Wright JS, Pelser C, Gulati M, Masoudi FA, Goff DC Jr. Estimating Longitudinal Risks and Benefits From Cardiovascular Preventive Therapies Among Medicare Patients: The Million Hearts Longitudinal ASCVD Risk Assessment Tool: A Special Report From the American Heart Association and American College of Cardiology. Circulation. 2017 Mar 28;135(13):e793-e813. doi: 10.1161/CIR.0000000000000467. Epub 2016 Nov 4. Erratum In: Circulation. 2017 Mar 28;135(13):e824-e825. — View Citation

Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883. — View Citation

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Zhang M, Wang B, Liu Y, Sun X, Luo X, Wang C, Li L, Zhang L, Ren Y, Zhao Y, Zhou J, Han C, Zhao J, Hu D. Cumulative increased risk of incident type 2 diabetes mellitus with increasing triglyceride glucose index in normal-weight people: The Rural Chinese Cohort Study. Cardiovasc Diabetol. 2017 Mar 1;16(1):30. doi: 10.1186/s12933-017-0514-x. — View Citation

Zhu B, Wang J, Chen K, Yan W, Wang A, Wang W, Gao Z, Tang X, Yan L, Wan Q, Luo Z, Qin G, Chen L, Mu Y. A high triglyceride glucose index is more closely associated with hypertension than lipid or glycemic parameters in elderly individuals: a cross-sectional survey from the Reaction Study. Cardiovasc Diabetol. 2020 Jul 14;19(1):112. doi: 10.1186/s12933-020-01077-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimate the prevelance of IR in obese patients based on TYG index .	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	Baseline
Primary	screen early cardiovascular abnormalities in obese asymptomatic patients	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	Baseline
Secondary	detect association of cardiovascular hemodynamics with TyG index .	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.	Baseline
Secondary	Assess cardiovascular risk in obese patients .	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.	Baseline

External Links

•   FRS risk score calculator
•   Obesity