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Paediatric Obesity and Cardiovascular Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03169257
Recruitment Status : Active, not recruiting
First Posted : May 30, 2017
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita

Brief 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.


Condition or disease Intervention/treatment Phase
Obesity, Childhood Cardiovascular Diseases Behavioral: diet plus physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Only one group, the obese children group (OB) will be followed for one year. At baseline they received a behavioral intervention which comprises a Mediterranean balanced diet plus daily aerobic training.
Masking: Single (Outcomes Assessor)
Masking Description: A sonographer will perform cardiovascular imaging. Images will be reviewed by an expert pediatric cardiologist and an expert vascular surgeon blinded to patients' clinical data.
Primary Purpose: Treatment
Official Title: Paediatric Obesity and Cardiovascular Dysfunction: Searching for Early Markers of Damage
Actual Study Start Date : January 15, 2015
Actual Primary Completion Date : February 8, 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OB
Obese subjects according to the International Obesity Task Force (IOTF) criteria aged 6 to 16 years. OB subjects will undergo for 12 months an isocaloric Mediterranen balanced diet plus a daily aerobic training for at least 60 minutes.
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.

No Intervention: NW
Normal weight subjects according to the International Obesity Task Force (IOTF) criteria aged 6 to 16 years and age, sex and pubertal status matched with the OB group



Primary Outcome Measures :
  1. Early cardiovascular abnormalities in OB patients compared with NW subjects [ Time Frame: Baseline: at study entry ]
    We performed transthoracic echocardiogram to all subjects. Measurements of left ventricle (LV), left atrium diameter (LAD), LA and LV volumes, LV systolic and diastolic function, LV mass and relative wall thickness were obtained and compared between OB and matched NW subjects. A vascular assessment was also performed which included carotid artery intima-media thickness (CIMT), abdominal aortic strain and stiffness and brachial artery flow-mediated dilation (FMD). All these measurements were compared between OB and NW subjects. A sample of 15 individuals has been estimated to be sufficient to demonstrate a difference of 10% in LV diameter with a standard deviation (SD) of 0.44 cm with 90% power and a significance level of 95% in the Student t-test between OB and NW according to published data.


Secondary Outcome Measures :
  1. Potential association of cardiovascular abnormalities with insulin resistance (IR) in the OB group [ Time Frame: Baseline: at study entry ]
    In the OB group, after a 12-h overnight fast, blood samples were taken for measurement of glucose and insulin using standardized methods in the Hospital's Laboratory. Obese subjects also underwent an OGTT. Insulin-resistance at fasting was calculated using the formula of homeostasis model assessment (HOMA)-IR. Insulin sensitivity at fasting and during OGTT was calculated as the formula of the Quantitative Insulin-Sensitivity Check Index (QUICKI) and Matsuda index (ISI).

  2. Potential association of cardiovascular abnormalities with serum uric acid (sUA) in the OB group [ Time Frame: Baseline: at study entry ]
    In the OB group, after a 12-h overnight fast, blood samples were taken for measurement of sUA using standardized methods in the Hospital's Laboratory. sUA was measured by Fossati method reaction.

  3. Potential association of cardiovascular abnormalities with metabolic syndrome (MetS) in the OB group [ Time Frame: Baseline: at study entry ]
    MetS was defined by using the modified National Cholesterol Education Program/Adult Treatment Panel III (NCEP-ATP III) criteria. A cohort of 75 obese subjects has been estimated to be sufficient to demonstrate differences among numbers of MetS criteria (0-5 criteria according to NCEP-ATPII classification).

  4. Variations of cardiovascular abnormalities in the OB group after 6 and 12 months of behavioral treatment [ Time Frame: After 6 and 12 months of behavioral (diet plus aerobic training) treatment ]
    OB subjects will perform cardiovascular assessment after 6 and 12 months of isocaloric Mediterranean balanced diet plus aerobic training.

  5. Association of cardiovascular abnormalities with IR in the OB group after 6 and 12 months of behavioral treatment [ Time Frame: After 6 and 12 months of behavioral (diet plus aerobic training) treatment ]
    In the OB group, after 6 and 12 month of behavioral treatment, blood samples were taken for measurement of glucose and insulin. Obese subjects also underwent an OGTT. Insulin-resistance at fasting was calculated using the formula of homeostasis model assessment (HOMA)-IR. Insulin sensitivity at fasting and during OGTT was calculated as the formula of the Quantitative Insulin-Sensitivity Check Index (QUICKI) and Matsuda index (ISI). IR will be correlated with cardiovascular measurements

  6. Association of cardiovascular abnormalities with sUA in the OB group after 6 and 12 months of behavioral treatment [ Time Frame: After 6 and 12 months of behavioral (diet plus aerobic training) treatment ]
    In the OB group, after 6 and 12 month of behavioral treatment, blood samples were taken for measurement of sUA. sUA will be correlated with cardiovascular measurements.

  7. Association of cardiovascular abnormalities with MetS in the OB group after 6 and 12 months of behavioral treatment [ Time Frame: After 6 and 12 months of behavioral (diet plus aerobic training) treatment ]
    In the OB group, after 6 and 12 month of behavioral treatment, the presence of MetS was evaluated. The presence/absence of MetS and the number of MetS criteria were correlated with cardiovascular measurements.

  8. Association between cardiovascular dysfunction and adiponectin, inflammatory and oxidative stress plasmatic markers. [ Time Frame: Baseline and after 6 and 12 months of behavioral (diet plus aerobic training) treatment ]
    In the OB group at all study time points, blood samples will be stored and will be analyzed for: IL-8, IL-10, IL-6, TNFα, PAI-1, adiponectin, 3-nitrotyrosine, MDA, ROS generation, MPO, GSH, SOD and NO. An ultrastructural and functional analysis of mitochondria will be also performed. All these dosages will be correlated with cardiovascular abnormalities.



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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children and adolescents (6-16 years);
  • obese (OB) and normal weight (NW, control group) according to the International Obesity Task Force (IOTF) criteria;
  • both genders;
  • diet naïve.

Exclusion Criteria:

  • specific causes of endocrine or genetic obesity;
  • type 1 or type 2 diabetes;
  • previous heart, respiratory, liver and kidney diseases,
  • current or past use of hormonal or interfering therapies (lipid-lowering, hypoglycemic, or antihypertensive treatments).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169257


Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
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Principal Investigator: Flavia Prodam, Prof Division of Pediatrics, Department of Health Sciences, University of Piemonte Orientale, Novara, Italy

Publications:

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Responsible Party: Flavia Prodam, Associated professor, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT03169257    
Other Study ID Numbers: CE 95/12
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita:
paediatric obesity
cardiovascular dysfunction
metabolic syndrome
adipokines
inflammation
oxidative stress
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms