Insulin ResistanceNCT06358989
Association Between Triglycerides Glucose Ratio With HOMA -IR as Indicators of Insulin Resistance in Obese Adults
An observational study of Insulin Resistance, run by Assiut University.
Trial summary
The aim of the present study was to investigate the correlation between the triglyceride/glucose index (TyG index) and homeostasic model assessment of insulin resistance (HOMA-IR) to predict insulin resistance (IR) in obese adults Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- HOMA IR
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 May 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 70 years
- All sexes
- Adult, Older adult
Study population: Any obese adult (18 years or older) with BMI greater than or equal 30 of both sexes admitted to assiut unversity hospitals and clinics
Who may be able to join
- Any obese adult (18 years or older) with BMI greater than or equal 30 of both sexes admitted to assiut unversity hospitals and clinics
Who cannot join
- Cases <18 years old
- Cases with BMI < 30
- Adult with endocrine abnormatilies under treatment for DM ,hypertension , dyslipidemia
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the present study was to investigate the correlation between the triglyceride/glucose index (TyG index) and homeostasic model assessment of insulin resistance (HOMA-IR) to predict insulin resistance (IR) in obese adults
Read the detailed description
Obesity is a chronic disease that has an increasing prevalence in both developed and developing countries and affects adults and children[1] Obesity is an important risk factor for the development of some chronic diseases such as insulin resistance, hypertension, and type 2 diabetes [2]
. Insulin sensitivity is inversely related to body mass index and body fat. Insulin resistance can be defined as impairment of the normal biological response to both endogenous and exogenous insulin. One of the primary defects underlying the development of type 2 diabetes is thought to be insulin resistance. So, it is present in 85% of these patients with Type 2 DM. It is also related to the pathogenesis of many illnesses which includes coronary heart disease, and hypertension[3] Early detection of insulin resistance (IR) is important to prevent the development of cardiometabolic diseases such as Type 2 Diabetes Mellitus, metabolic syndrome, and coronary heart disease. The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index, which has high sensitivity and specificity, has been shown to be more useful in estimating the risk of insulin resistance, instead of more invasive, complex, and expensive direct tests such as pancreatic suppression test and hyperinsulinemic-euglycemic glucose clamp technique [4] HOMA-IR is an approved method for evaluating insulin resistance using fasting glucose and insulin levels and is widely used in clinical practice [5].
Triglyceride glucose (TyG) index is a novel marker, which has been demonstrated to have a high sensitivity and specificity in identifying insulin resistance [6].
Recently, the use of the triglyceride glucose (TyG) index, a product of fasting glucose and triglyceride are more easily accessible assessment tools both at the outpatient clinics and at the community level, and are low cost [7].
- Conditions
- Insulin Resistance
- Being tested
- HOMA IR
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOMA IROther
Homa ir
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between triglycerides glucose ratio with HOMA -IR as indicators of insulin resistance in obese adults
The study is to investigate the usability of the Ty-G index as an indicator of insulin resistance in obese adults according to its correlation with HOMA-IR
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Esmat Mohamed Kotb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358989
- Sponsor's protocol ID
- Insulin resistance
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PubMed 16595758Bittner V, Johnson BD, Zineh I, Rogers WJ, Vido D, Marroquin OC, Bairey-Merz CN, Sopko G. The triglyceride/high-density lipoprotein cholesterol ratio predicts all-cause mortality in women with suspected myocardial ischemia: a report from the Women's Ischemia Syndrome Evaluation (WISE). Am Heart J. 2009 Mar;157(3):548-55. doi: 10.1016/j.ahj.2008.11.014.
PubMed 19249427
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Triglycerides Glucose Ratio With HOMA -IR as Indicators of Insulin Resistance in Obese Adults
- ClinicalTrials.gov ID
- NCT06358989
- Acronym / sponsor ID
- Insulin resistance
- Conditions
- Insulin Resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 11 Apr 2024 (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.
The aim of the present study was to investigate the correlation between the triglyceride/glucose index (TyG index) and homeostasic model assessment of insulin resistance (HOMA-IR) to predict insulin resistance (IR) in obese adults
Detailed description
Obesity is a chronic disease that has an increasing prevalence in both developed and developing countries and affects adults and children[1] Obesity is an important risk factor for the development of some chronic diseases such as insulin resistance, hypertension, and type 2 diabetes [2]
. Insulin sensitivity is inversely related to body mass index and body fat. Insulin resistance can be defined as impairment of the normal biological response to both endogenous and exogenous insulin. One of the primary defects underlying the development of type 2 diabetes is thought to be insulin resistance. So, it is present in 85% of these patients with Type 2 DM. It is also related to the pathogenesis of many illnesses which includes coronary heart disease, and hypertension[3] Early detection of insulin resistance (IR) is important to prevent the development of cardiometabolic diseases such as Type 2 Diabetes Mellitus, metabolic syndrome, and coronary heart disease. The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index, which has high sensitivity and specificity, has been shown to be more useful in estimating the risk of insulin resistance, instead of more invasive, complex, and expensive direct tests such as pancreatic suppression test and hyperinsulinemic-euglycemic glucose clamp technique [4] HOMA-IR is an approved method for evaluating insulin resistance using fasting glucose and insulin levels and is widely used in clinical practice [5].
Triglyceride glucose (TyG) index is a novel marker, which has been demonstrated to have a high sensitivity and specificity in identifying insulin resistance [6].
Recently, the use of the triglyceride glucose (TyG) index, a product of fasting glucose and triglyceride are more easily accessible assessment tools both at the outpatient clinics and at the community level, and are low cost [7].
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any obese adult (18 years or older) with BMI greater than or equal 30 of both sexes admitted to assiut unversity hospitals and clinics
Key inclusion criteria (1 listed)
- Any obese adult (18 years or older) with BMI greater than or equal 30 of both sexes admitted to assiut unversity hospitals and clinics
Key exclusion criteria (3 listed)
- Cases <18 years old
- Cases with BMI < 30
- Adult with endocrine abnormatilies under treatment for DM ,hypertension , dyslipidemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOMA IRHoma ir | Other | – |
Primary outcome
Association between triglycerides glucose ratio with HOMA -IR as indicators of insulin resistance in obese adults
Time frame: Baseline
The study is to investigate the usability of the Ty-G index as an indicator of insulin resistance in obese adults according to its correlation with HOMA-IR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Background: PubMed 16595758Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Background: PubMed 19249427Bittner V, Johnson BD, Zineh I, Rogers WJ, Vido D, Marroquin OC, Bairey-Merz CN, Sopko G. The triglyceride/high-density lipoprotein cholesterol ratio predicts all-cause mortality in women with suspected myocardial ischemia: a report from the Women's Ischemia Syndrome Evaluation (WISE). Am Heart J. 2009 Mar;157(3):548-55. doi: 10.1016/j.ahj.2008.11.014.
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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 Insulin Resistance, 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 3 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 11 Apr 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 Ayat Esmat (01061135187, Ayatesmat55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between triglycerides glucose ratio with HOMA -IR as indicators of insulin resistance in obese adults (time frame: Baseline). 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 NCT06358989, which also lists 2 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 11 Apr 2024.