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Obesity, ChildhoodNCT05371821

Cardiac Assessment in Obese and Overweight Children

An observational study of Obesity, Childhood, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Is to assess cardiac functions of overweight and obese children attending assiut University children hospital in one year duration . Read more about this study

Who is it for?
Ages 2 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood
What is being tested?
Echocardiography
Type of treatment
Medical device
How many people
50 participants
Where
No sites listed yet
Study dates
20 May 2022to May 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 2 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Obese and overweight children from 2 years till age of 18 years .

Who may be able to join

  • - Age: children at 2-18 years .
  • - Overweight children whose body mass index at or above the 85th percentile and below the 95th percentile for the same age and sex
  • - Obese children whose body mass index at or above the 95th percentile for the same age and sex.

Who cannot join

  • 1- Obese children below two years 2 - Cases with syndromic obesity, diabetes
  • thyroid and parathyroid and those with congenital heart diseases

Trial locations and contacts

No sites are listed yet.

Osman G Hassan, MD contact

+201019058968

osmanelsafawy@gmail.com

Osama M Al Asheer, Professor contact

+201001348864

osamaelasheer@med.edu.eg

About this study

Official title: Cardiac Assessment of Obese and Overweight Children Attending Asyut University Children Hospital

Is to assess cardiac functions of overweight and obese children attending assiut University children hospital in one year duration .

Read the detailed description

The prevalence of overweight and obesity in children is increasing worldwide at an alarming rate in both developing and developed countries .the relation between obesity and cardiac structure and function in children is less well documented and conflicting results have been reported .In addition, obesity is associated with a heterogeneity of metabolic abnormalities , (e.g., dyslipidemia , insulin resistance hyperglycaemia and hypertension , that may provide a plausible biologic link between obesity and the increased risk of cardiovascular morbidity and mortality .The clustering of these risk factors for cardiovascular disease is referred to as the "metabolic syndrome." Although the concept and definition of the metabolic syndrome are controversial at the moment, there is no doubt that a cluster of cardiovascular risk factors is present in obese children and adolescents and that their presence increases with worsening obesity .children are likely to be the ideal candidates for providing insight into the myocardial changes related to obesity because they are suggested to be free of other cardiovascular risk factors indifferent echocardiographic studies .

Being tested
Echocardiography
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac assessment of obese and overweight children

    Echocardiography performed by an expert cardiologist using a Philips envisor c machine to assess the following parameters (left ventricle end-diastolic diameter (LVEDD), left ventricle end-systolic diameter (LVESD), interventricular septal systolic diameter (IVSSD), interventricular septal diastolic diameter (IVSDD) left ventricle fraction shortening (FS), left ventricle ejection fraction (EF), left atrium to aorta ratio (LA:AO), mitral annular plane area systolic excursion (MAPSE), fraction area shortening of the right ventricle (FAC), tricuspid annular plane systolic excursion (TAPSE)

    Measured: Baseline

  2. Assessment of body mass index

    BMI described in kg / m²

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2022
  2. Study start20 May 2022 (estimated)
  3. Primary completion21 Apr 2023 (estimated)
  4. Study completionMay 2023 (estimated)

Resources

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
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05371821
Sponsor's protocol ID
assessment of obese children
Status last verified
May 2022
First submitted
23 Apr 2022
Last updated
12 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bates JH, Serdula MK, Khan LK, Jones DA, Macera CA, Ainsworth BE. Intensity of physical activity and risk of coronary heart disease. JAMA. 2001 Jun 20;285(23):2973; author reply 2974. No abstract available.

    PubMed 11410086

  • de Simone G, Daniels SR, Devereux RB, Meyer RA, Roman MJ, de Divitiis O, Alderman MH. Left ventricular mass and body size in normotensive children and adults: assessment of allometric relations and impact of overweight. J Am Coll Cardiol. 1992 Nov 1;20(5):1251-60. doi: 10.1016/0735-1097(92)90385-z.

    PubMed 1401629

  • Kono Y, Yoshinaga M, Oku S, Nomura Y, Nakamura M, Aihoshi S. Effect of obesity on echocardiographic parameters in children. Int J Cardiol. 1994 Aug;46(1):7-13. doi: 10.1016/0167-5273(94)90111-2.

    PubMed 7960279

  • Yoshinaga M, Yuasa Y, Hatano H, Kono Y, Nomura Y, Oku S, Nakamura M, Kanekura S, Otsubo K, Akiba S, et al. Effect of total adipose weight and systemic hypertension on left ventricular mass in children. Am J Cardiol. 1995 Oct 15;76(11):785-7. doi: 10.1016/s0002-9149(99)80227-6.

    PubMed 7572655

  • Daniels SR, Kimball TR, Morrison JA, Khoury P, Witt S, Meyer RA. Effect of lean body mass, fat mass, blood pressure, and sexual maturation on left ventricular mass in children and adolescents. Statistical, biological, and clinical significance. Circulation. 1995 Dec 1;92(11):3249-54. doi: 10.1161/01.cir.92.11.3249.

    PubMed 7586311

  • Goran MI, Gower BA. Abdominal obesity and cardiovascular risk in children. Coron Artery Dis. 1998;9(8):483-7. doi: 10.1097/00019501-199809080-00003. No abstract available.

    PubMed 9847979

  • Steinberger J, Daniels SR; American Heart Association Atherosclerosis, Hypertension, and Obesity in the Young Committee (Council on Cardiovascular Disease in the Young); American Heart Association Diabetes Committee (Council on Nutrition, Physical Activity, and Metabolism). Obesity, insulin resistance, diabetes, and cardiovascular risk in children: an American Heart Association scientific statement from the Atherosclerosis, Hypertension, and Obesity in the Young Committee (Council on Cardiovascular Disease in the Young) and the Diabetes Committee (Council on Nutrition, Physical Activity, and Metabolism). Circulation. 2003 Mar 18;107(10):1448-53. doi: 10.1161/01.cir.0000060923.07573.f2. No abstract available.

    PubMed 12642369

  • Aggoun Y. Obesity, metabolic syndrome, and cardiovascular disease. Pediatr Res. 2007 Jun;61(6):653-9. doi: 10.1203/pdr.0b013e31805d8a8c.

    PubMed 17426660

  • Weiss R, Dziura J, Burgert TS, Tamborlane WV, Taksali SE, Yeckel CW, Allen K, Lopes M, Savoye M, Morrison J, Sherwin RS, Caprio S. Obesity and the metabolic syndrome in children and adolescents. N Engl J Med. 2004 Jun 3;350(23):2362-74. doi: 10.1056/NEJMoa031049.

    PubMed 15175438

  • Di Salvo G, Pacileo G, Del Giudice EM, Natale F, Limongelli G, Verrengia M, Rea A, Fratta F, Castaldi B, D'Andrea A, Calabro P, Miele T, Coppola F, Russo MG, Caso P, Perrone L, Calabro R. Abnormal myocardial deformation properties in obese, non-hypertensive children: an ambulatory blood pressure monitoring, standard echocardiographic, and strain rate imaging study. Eur Heart J. 2006 Nov;27(22):2689-95. doi: 10.1093/eurheartj/ehl163. Epub 2006 Aug 11.

    PubMed 16905554

  • Labombarda F, Zangl E, Dugue AE, Bougle D, Pellissier A, Ribault V, Maragnes P, Milliez P, Saloux E. Alterations of left ventricular myocardial strain in obese children. Eur Heart J Cardiovasc Imaging. 2013 Jul;14(7):668-76. doi: 10.1093/ehjci/jes238. Epub 2012 Nov 15.

    PubMed 23161790

  • Li X, Li S, Ulusoy E, Chen W, Srinivasan SR, Berenson GS. Childhood adiposity as a predictor of cardiac mass in adulthood: the Bogalusa Heart Study. Circulation. 2004 Nov 30;110(22):3488-92. doi: 10.1161/01.CIR.0000149713.48317.27. Epub 2004 Nov 22.

    PubMed 15557363

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Childhood, 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 3 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 12 May 2022. 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 Osman G Hassan, MD (+201019058968, osmanelsafawy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac assessment of obese and overweight children (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 NCT05371821, which also lists 12 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 12 May 2022.

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