Heart FailureNCT05663632
Triglyceride-Glucose Index In Heart Failure Patients In Sohag University Hospital
An observational study of Heart Failure and Insulin Resistance, run by Sohag University at 1 site in Egypt.
Trial summary
study the relationship between Triglyceride glucose index and heart failure patients Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure, Insulin Resistance
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2022to Jun 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be divided into2 groups, as following: Group (1) Heart Failure patients (100 patients) Group (2) control group(100 person) All groups will be subjected to : 1. Complete history taking with special emphasis on Age ,Sex, Smoking, Diabetes mellitus and Hypertension. 2. A thorough clinical examination will stress on: 1- Heart rate (b.p.m.). 2-Systolic BP (mmHg). 3-BMI calculated as the ( weight (kg)/height (m)2). 3-The following investigations will be done to every subject: 1. FBG (mg/dL) 2. FTG, (mg/dL) 3. Total cholesterol (TC) (mg/dL) 4. SCr (mg/dL) 5. Echocardiography TyG index is calculated as ln [fasting triglyceride (mg/dL) * fasting glucose (mg/dL) / 2]
Who may be able to join
- All Heart Failure patients attend to sohag university hospital aged above 18 year old .
Who cannot join
- Patients on lipid lowering medications
- Patients on antidiabetic drugs
- Patients with comorbidities eg liver cirrhosis or malignancy
Trial locations and contacts
1 site in 1 country.
Ali T Taha, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, professor
About this study
study the relationship between Triglyceride glucose index and heart failure patients
- Conditions
- Heart Failure, Insulin Resistance
- Keywords
- heart failure, triglyceride-glucose index
- Medical subject headings
- Heart Failure, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 heart failure patients | Not described | |
| Group 2 controle | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride-Glucose Index in Heart Failure Patients
identify the relationship between Triglyceride-Glucose Index and heart failure patients in Sohag University hospital
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start12 Dec 2022
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Khairy Shabaan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663632
- Sponsor's protocol ID
- Soh-Med-22-12-04
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
PubMed 33069326Davison B, Cotter G. Why is heart failure so important in the 21st century? Eur J Heart Fail. 2015 Feb;17(2):122-4. doi: 10.1002/ejhf.219. Epub 2014 Dec 30. No abstract available.
PubMed 25557121Miller M, Seidler A, Moalemi A, Pearson TA. Normal triglyceride levels and coronary artery disease events: the Baltimore Coronary Observational Long-Term Study. J Am Coll Cardiol. 1998 May;31(6):1252-7. doi: 10.1016/s0735-1097(98)00083-7.
PubMed 9581716Shaye K, Amir T, Shlomo S, Yechezkel S. Fasting glucose levels within the high normal range predict cardiovascular outcome. Am Heart J. 2012 Jul;164(1):111-6. doi: 10.1016/j.ahj.2012.03.023.
PubMed 22795290
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triglyceride-Glucose Index In Heart Failure Patients In Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05663632
- Acronym / sponsor ID
- Soh-Med-22-12-04
- Conditions
- Heart Failure, Insulin Resistance
- Keywords
- heart failure, triglyceride-glucose index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 23 Dec 2022 (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.
study the relationship between Triglyceride glucose index and heart failure patients
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 heart failure patients | – | – |
| Group 2 controle | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be divided into2 groups, as following: Group (1) Heart Failure patients (100 patients) Group (2) control group(100 person) All groups will be subjected to : 1. Complete history taking with special emphasis on Age ,Sex, Smoking, Diabetes mellitus and Hypertension. 2. A thorough clinical examination will stress on: 1- Heart rate (b.p.m.). 2-Systolic BP (mmHg). 3-BMI calculated as the ( weight (kg)/height (m)2). 3-The following investigations will be done to every subject: 1. FBG (mg/dL) 2. FTG, (mg/dL) 3. Total cholesterol (TC) (mg/dL) 4. SCr (mg/dL) 5. Echocardiography TyG index is calculated as ln [fasting triglyceride (mg/dL) * fasting glucose (mg/dL) / 2]
Key inclusion criteria (1 listed)
- All Heart Failure patients attend to sohag university hospital aged above 18 year old .
Key exclusion criteria (3 listed)
- Patients on lipid lowering medications
- Patients on antidiabetic drugs
- Patients with comorbidities eg liver cirrhosis or malignancy
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
Triglyceride-Glucose Index in Heart Failure Patients
Time frame: 6 months
identify the relationship between Triglyceride-Glucose Index and heart failure patients in Sohag University hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Background: PubMed 33069326GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
- Background: PubMed 25557121Davison B, Cotter G. Why is heart failure so important in the 21st century? Eur J Heart Fail. 2015 Feb;17(2):122-4. doi: 10.1002/ejhf.219. Epub 2014 Dec 30. No abstract available.
- Background: PubMed 9581716Miller M, Seidler A, Moalemi A, Pearson TA. Normal triglyceride levels and coronary artery disease events: the Baltimore Coronary Observational Long-Term Study. J Am Coll Cardiol. 1998 May;31(6):1252-7. doi: 10.1016/s0735-1097(98)00083-7.
- Background: PubMed 22795290Shaye K, Amir T, Shlomo S, Yechezkel S. Fasting glucose levels within the high normal range predict cardiovascular outcome. Am Heart J. 2012 Jul;164(1):111-6. doi: 10.1016/j.ahj.2012.03.023.
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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.
Ali T Taha, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Insulin Resistance, run by Sohag University at 1 site in Egypt.
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 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Aliaa k Khyry, resident doctor (01067655291, aliaakhairy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglyceride-Glucose Index in Heart Failure Patients (time frame: 6 months). 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 NCT05663632, which also lists 4 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 23 Dec 2022.