ObesityNCT05702112
Association of Triglyceride-glucose Index With Cardiac Hemodynamics
An observational study of Obesity, run by Assiut University.
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 . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Apr 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: obese patients over two years duration
Who may be able to join
- 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 )
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Association of Triglyceride-glucose Index With Cardiac Hemodynamics and Cardiovascular Risk Assesment in Obese Patient.
- 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 .
Read the 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 . 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.
- Conditions
- Obesity
- Keywords
- TyG index, Cardiac hemodynamics
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: Baseline
Secondary outcomes (2)
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study startSep 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Hany, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702112
- Sponsor's protocol ID
- TyGI in cardiac hemodynamics
- Status last verified
- Aug 2024
- First submitted
- 19 Jan 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32664945Matthews 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.
PubMed 3899825Guerrero-Romero F, Simental-Mendia LE, Gonzalez-Ortiz M, Martinez-Abundis E, Ramos-Zavala MG, Hernandez-Gonzalez SO, Jacques-Camarena O, Rodriguez-Moran M. The product of triglycerides and glucose, a simple measure of insulin sensitivity. Comparison with the euglycemic-hyperinsulinemic clamp. J Clin Endocrinol Metab. 2010 Jul;95(7):3347-51. doi: 10.1210/jc.2010-0288. Epub 2010 May 19.
PubMed 20484475Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.
PubMed 24880830Zhang 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.
PubMed 28249577Lloyd-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.
PubMed 27815375D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
PubMed 18212285
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Triglyceride-glucose Index With Cardiac Hemodynamics and Cardiovascular Risk Assesment in Obese Patient.
- ClinicalTrials.gov ID
- NCT05702112
- Acronym / sponsor ID
- TyGI in cardiac hemodynamics
- Conditions
- Obesity
- Keywords
- TyG index, Cardiac hemodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 27 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.
- 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 .
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 . 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- obese patients over two years duration
Key inclusion criteria (1 listed)
- 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 )
Key exclusion criteria (2 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
estimate the prevelance of IR in obese patients based on TYG index .
Time frame: 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
screen early cardiovascular abnormalities in obese asymptomatic patients
Time frame: 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
2 secondary outcomes
detect association of cardiovascular hemodynamics with TyG index .
Time frame: Baseline
Assess cardiovascular risk in obese patients .
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 21 Aug 2024.
- Background: PubMed 32664945Zhu 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.
- Background: PubMed 3899825Matthews 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.
- Background: PubMed 20484475Guerrero-Romero F, Simental-Mendia LE, Gonzalez-Ortiz M, Martinez-Abundis E, Ramos-Zavala MG, Hernandez-Gonzalez SO, Jacques-Camarena O, Rodriguez-Moran M. The product of triglycerides and glucose, a simple measure of insulin sensitivity. Comparison with the euglycemic-hyperinsulinemic clamp. J Clin Endocrinol Metab. 2010 Jul;95(7):3347-51. doi: 10.1210/jc.2010-0288. Epub 2010 May 19.
- Background: PubMed 24880830Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.
- Background: PubMed 28249577Zhang 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.
- Background: PubMed 27815375Lloyd-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.
- Background: PubMed 18212285D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
- ObesityLink provided by the sponsor.
- FRS risk score calculatorLink provided by the sponsor.
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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 Obesity, 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 2 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 21 Aug 2024. 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 Michael Hany Shawky (01009431082, Michaelhany544@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimate the prevelance of IR in obese patients based on TYG index . (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702112, which also lists 7 linked publications.
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 21 Aug 2024.