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Cardiovascular risk factors and subclinical atherosclerosis in children and adolescents with congenital heart disease

Association of dietary patterns, inflammation and intestinal microbiota with subclinical atherosclerosis in children and adolescents with congenital heart disease undergoing cardiac procedure

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-66nkyy3
Enrollment
Unknown
Registered
2021-09-12
Start date
2017-01-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Interventions

Follow-up study, longitudinal, prospective with 345 children and adolescents with congenital heart disease. The aim of the study is to investigate the association of dietary patterns, inflammation and
E05.318.308.980

Sponsors

Universidade Federal de Santa Catarina
Lead Sponsor
Universidade Federal de Santa Catarina
Collaborator
Hospital Universitário Polydoro Ernani de São Tiago/UFSC
Collaborator
Hospital Infantil Joana de Gusmão
Collaborator

Eligibility

Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children and adolescents aged 5 to 18 years; of both sexes; diagnosed with congenital heart disease; underwent some type of cardiac procedure (therapeutic catheterization or cardiac surgery)

Exclusion criteria

Exclusion criteria: Secondary diagnosis, as malignant neoplasm, chromosomal abnormalities (trisomy 21, Turner, Noonan and others); primary or secondary familial dyslipidemia; diabetes mellitus; hypothyroidism; acute diseases in the last 15 days (Respiratory and gastrointestinal infections); other chronic inflammatory diseases (Lupus, hepatitis, arthritis, asthma, intestinal syndromes and others).

Design outcomes

Primary

MeasureTime frame
To evaluate subclinical atherosclerosis using the carotid intima-media thickness method, expressed in mm

Secondary

MeasureTime frame
To evaluate central obesity using the waist circumference method, expressed in percentile for age and sex ;To evaluate inflammation using determination method to cytokine (IL-2, IL-4, IL-6, IL-10, tumor necrosis factor protein (TNF), Interferon-y (IFN-y) and IL-17a) using flow cytometry method, expressed in pg/mL, C-reactive protein by immunonephelometry method, expressed in mg/L, and vascular and intercellular adhesion molecules using ELISA kit, expressed in ng/mL;To evaluate dyslipidemia using lipid parameters (total cholesterol, HDL-c, LDL-C, non-HDL-c and triglycerides) using an colorimetric enzymatic method, expressed in mg/dL ;To evaluate diabetes using glycemic parameters (fasting glucose, using colorimetric enzymatic method, expressed in mg/dl, insulin, using immunometric chemiluminescence assay, expressed in µUI/mL and HOMA-IR by formula: fasting insulin x fasting glucose/22.5²);To evaluate hypertension using a standard method with mercury sphygmomanometer with an appropriately sized cuff according to the arm circumference, expressed in percentile

Countries

Brazil

Contacts

Public ContactYara Maria;Michele Moreno;Honicky

Universidade Federal de Santa Catarina;

yarafmoreno@gmail.com;michele_honicky@yahoo.com.br+55 48 37212215;+55 47 997624767

Outcome results

None listed

Source: REBEC (via WHO ICTRP)