ObesityNCT06127082
Left Cardiac Chambers Size in Obese Individuals and Its Relation to BMI and Waist Circumference
An observational study of Obesity, run by Assiut University.
Trial summary
Aim of study: To determine if there is relation between left cardiac chambers size ,BMI and waist circumference in obese individuals. 1. Primary outcomes: -To determine if there is relation between left cardiac chambers size ,BMI and waist circumference in obese individuals. 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Echocardiography
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 May 2026
- 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: - 1-Patient age 18 years old or above. 2-Patient BMI 30kg/m2 or higher . 3-Patient waist circumference in men 102cm or more and in women 88cm or more. 4-Obese patient with comorbidities (e.g DM,HTN).
Who may be able to join
- 1-Patient age 18 years old or above. 2-Patient BMI 30kg/m2 or higher . 3-Patient waist circumference in men 102cm or more and in women 88cm or more. 4-Obese patient with comorbidities (e.g DM,HTN).
Who cannot join
- 1-Patient age 18 years old. 2-Patient BMI less than 30 kg/m2. 3-Patient waist circumference in men less than 102cm and in women less than 88cm.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Left Cardiac Chambers Size in Obese Individuals and Its Relation to BMI and Waist
Aim of study:
To determine if there is relation between left cardiac chambers size ,BMI and waist circumference in obese individuals.
- Primary outcomes: -To determine if there is relation between left cardiac chambers size ,BMI and waist circumference in obese individuals.
- Secondary outcomes:
- To determine the effect of obesity on heart health in obese individuals.
Read the detailed description
Body mass index and waist circumference are important measurements of our bodies as they can affect our health.The person is obese if he has BMI equal 30 or higher.Increased risk of obesity related disease occurs in men with waist circumference equal 102 cm or more and woman with waist circumference equals 88 cm or more. increasing BMI and waist circumference can increase risk of type 2 diabetes mellitus ,hypertension ,cardiovascular disease and cerebrovascular accidents.There are many diseases that can affect left cardiac chambers size like aortic, mitral valvediseases,hypertension and atherosclerosis.Screening of patients heart by echocardiography allow us to detect changes in the muscle of heart and this allow doctors to put treatment plan to patient to prevent heart health from deterioration. In this study the investigators want to know if there an association between left cardiac chambers size ,BMI and waist circumference in obese individuals.
- Conditions
- Obesity
- Being tested
- Echocardiography
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDevice
Do echocardiography to obese patient
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if there is correlation between left cardiac chambers size in mm ,BMI in kg/m^2 and waist circumference in cm in obese individuals
effect of obesity on left cardiac chambers size
Measured: Baseline
Secondary outcomes (1)
To determine the effect of obesity on heart health in obese individuals.
effect of obesity on left cardiac chambers size
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Baha Elia, Assiut University
- Investigators
- Walaa Anwar, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127082
- Sponsor's protocol ID
- The effect of obesity on heart
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moukarzel J, Guevara E, Casciaro ME, Guilenea FN, Pascaner AF, Craiem D. Echocardiographic Measurements of Left Heart Chamber Size in a Large Cohort of Subjects: Comparison of Body Surface Area and Height Indexing to Account for Effects of Obesity. J Am Soc Echocardiogr. 2022 Nov;35(11):1159-1167.e2. doi: 10.1016/j.echo.2022.08.001. Epub 2022 Aug 8.
PubMed 35953008
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Cardiac Chambers Size in Obese Individuals and Its Relation to BMI and Waist
- ClinicalTrials.gov ID
- NCT06127082
- Acronym / sponsor ID
- The effect of obesity on heart
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 13 Nov 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.
Aim of study:
To determine if there is relation between left cardiac chambers size ,BMI and waist circumference in obese individuals.
- Primary outcomes: -To determine if there is relation between left cardiac chambers size ,BMI and waist circumference in obese individuals.
- Secondary outcomes:
- To determine the effect of obesity on heart health in obese individuals.
Detailed description
Body mass index and waist circumference are important measurements of our bodies as they can affect our health.The person is obese if he has BMI equal 30 or higher.Increased risk of obesity related disease occurs in men with waist circumference equal 102 cm or more and woman with waist circumference equals 88 cm or more. increasing BMI and waist circumference can increase risk of type 2 diabetes mellitus ,hypertension ,cardiovascular disease and cerebrovascular accidents.There are many diseases that can affect left cardiac chambers size like aortic, mitral valvediseases,hypertension and atherosclerosis.Screening of patients heart by echocardiography allow us to detect changes in the muscle of heart and this allow doctors to put treatment plan to patient to prevent heart health from deterioration. In this study the investigators want to know if there an association between left cardiac chambers size ,BMI and waist circumference in obese individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - 1-Patient age 18 years old or above. 2-Patient BMI 30kg/m2 or higher . 3-Patient waist circumference in men 102cm or more and in women 88cm or more. 4-Obese patient with comorbidities (e.g DM,HTN).
Key inclusion criteria (1 listed)
- 1-Patient age 18 years old or above. 2-Patient BMI 30kg/m2 or higher . 3-Patient waist circumference in men 102cm or more and in women 88cm or more. 4-Obese patient with comorbidities (e.g DM,HTN).
Key exclusion criteria (1 listed)
- 1-Patient age 18 years old. 2-Patient BMI less than 30 kg/m2. 3-Patient waist circumference in men less than 102cm and in women less than 88cm.
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 |
|---|---|---|
| EchocardiographyDo echocardiography to obese patient | Device | – |
Primary outcome
To determine if there is correlation between left cardiac chambers size in mm ,BMI in kg/m^2 and waist circumference in cm in obese individuals
Time frame: Baseline
effect of obesity on left cardiac chambers size
1 secondary outcome
To determine the effect of obesity on heart health in obese individuals.
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 28 Nov 2023.
- Background: PubMed 35953008Moukarzel J, Guevara E, Casciaro ME, Guilenea FN, Pascaner AF, Craiem D. Echocardiographic Measurements of Left Heart Chamber Size in a Large Cohort of Subjects: Comparison of Body Surface Area and Height Indexing to Account for Effects of Obesity. J Am Soc Echocardiogr. 2022 Nov;35(11):1159-1167.e2. doi: 10.1016/j.echo.2022.08.001. Epub 2022 Aug 8.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Walaa Anwar, professor study director
Assiut University
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 1 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 28 Nov 2023. 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 Baha, Resident (01284368305, michaelbaha43@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if there is correlation between left cardiac chambers size in mm ,BMI in kg/m^2 and waist circumference in cm in obese individuals (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 NCT06127082, which also lists 1 linked publication.
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 28 Nov 2023.