NCT05371821

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

April 23, 2022

Last Update Submit

May 10, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

    Baseline

  • Assessment of body mass index

    BMI described in kg / m²

    baseline

Interventions

Echocardiographic parameters in obese and overweight

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Osman G Hassan, MD

CONTACT

Osama M Al Asheer, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiac assessment of obese and overweight children attending Asyut University children hospital

Study Record Dates

First Submitted

April 23, 2022

First Posted

May 12, 2022

Study Start

May 20, 2022

Primary Completion

April 21, 2023

Study Completion

May 1, 2023

Last Updated

May 12, 2022

Record last verified: 2022-05