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Paediatric Obesity and Cardiovascular Dysfunction

NCT03169257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-07-24

No results posted yet for this study

Summary

Background Childhood obesity has been related to an impaired cardiovascular structure and function. Aims of this study will be to evaluate early cardiovascular abnormalities in a large population of obese children and adolescents compared with a normal weight counterpart, to investigate the potential association with insulin resistance (IR), serum uric acid (sUA), metabolic syndrome (MetS), plasmatic markers of inflammation and oxidative stress and adipokines, to evaluate changes in cardiovascular dysfunction after 6 and 12 months of a behavioral treatment (isocaloric Mediterranean balanced diet plus daily aerobic physical activity).

Subjects and methods This was a single-center case-control study. Eighty obese (OB) subjects (6-16 years) and 20 normal weight (NW) matched controls were consecutively recruited. In the whole population we will perform an anthropometric and a cardiovascular assessment. OB patients will also undergo an OGTT and biochemical evaluations. In the OB group, all these evaluations will be performed at baseline and after 6 (T6) and 12 months (T12) of diet plus aerobic training.

Conditions

Interventions

BEHAVIORAL

diet plus physical activity

OB subjects will undergo an isocaloric Mediterranen balanced diet plus a daily aerobic training for at least 60 minutes. All the evaluations will be performed at baseline and after 6 and 12 months of this behavioral therapy. To assess food consumption, foods will be divided according to the classic basic food groups by the Italian Institute of Research on Food and Nutrition. Food frequencies questionnaires, validated for a wide range of ages, will be also completed by parents. Physical activity will be recorded by parents daily on a specific questionnaire.

Sponsors & Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    lead OTHER

Principal Investigators

  • Flavia Prodam, Prof · Division of Pediatrics, Department of Health Sciences, University of Piemonte Orientale, Novara, Italy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-15
Primary Completion
2017-02-08
Completion
2023-07-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03169257 on ClinicalTrials.gov