Cardiac Assessment in Obese and Overweight Children

Obesity, Childhood Clinical Trial

Official title:

Cardiac Assessment of Obese and Overweight Children Attending Asyut University Children Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05371821
• Other study ID #: assessment of obese children
• Status: Not yet recruiting
• Start date: May 20, 2022
• Est. completion date: May 2023

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: Osman G Hassan, MD
• Phone: +201019058968
• Email: osmanelsafawy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

1. - Age: children at 2-18 years .

2. - Overweight children whose body mass index at or above the 85th percentile and below the 95th percentile for the same age and sex

3. - Obese children whose body mass index at or above the 95th percentile for the same age and sex. Exclusion Criteria: 1- Obese children below two years 2 - Cases with syndromic obesity, diabetes

• thyroid and parathyroid and those with congenital heart diseases

Related Conditions & MeSH terms

• Obesity, Childhood
• Overweight
• Pediatric Obesity

Intervention

Device:
• Echocardiography
Echocardiographic parameters in obese and overweight

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (12)

Aggoun Y. Obesity, metabolic syndrome, and cardiovascular disease. Pediatr Res. 2007 Jun;61(6):653-9. Review. — View Citation

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. — View Citation

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. Circulatio — View Citation

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) — View Citation

Di Salvo G, Pacileo G, Del Giudice EM, Natale F, Limongelli G, Verrengia M, Rea A, Fratta F, Castaldi B, D'Andrea A, Calabrò P, Miele T, Coppola F, Russo MG, Caso P, Perrone L, Calabrò R. Abnormal myocardial deformation properties in obese, non-hypertensi — View Citation

Goran MI, Gower BA. Abdominal obesity and cardiovascular risk in children. Coron Artery Dis. 1998;9(8):483-7. Review. — View Citation

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. — View Citation

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. Epu — View Citation

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. Epub 2004 Nov 22. — View Citation

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 Activit — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Assessment of body mass index	BMI described in kg / m²	baseline