Longitudinal Assessment of Cardiovascular and Metabolic Parameters in Obese and Lean Children

Study Overview
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Brief Summary
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The investigators hypothesize that cardiovascular and metabolic alterations due to obesity already manifest at childhood age. To identify these alterations and risk factors, the investigators have established a cohort of 177 healthy obese and lean control children, age ranging from 6y to 18y, for evaluation of cardiovascular and metabolic parameters, as well as quantification of biomarkers of obesity and inflammation. Follow-up analyses are planned after 2 years (completed) and additionally after 5, 7 and 9 years. In addition, the investigators will assess the effects of increased physical activity and exercise on cardiovascular function.

Official Title
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Leipzig Artherobesity Childhood Cohort

Conditions
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Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: height -2 to +2 SDS pubertal stage adequate for age no medications written consent of guardians and children≥12y weight ≥ -2 SDS Exclusion Criteria: secondary/syndromal obesity known existing hypertension chronic disease (eg. errors of metabolism) acute illness (eg. respiratory tract infection) previous hypertensive or antidiabetic treatment- weight loss attempts 6 weeks prior to assessment

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lean children<br>n=100 (anticipated), n=70 currently Age: 6-25 years BMI-SDS: -1.88 to +1.23 , currently -0.25±0.77; Height-SDS: > - 2 SDS, currently 0.03±1.07; | |
| Obese children<br>n=106 Age: 6-25 years BMI-SDS: >1.23 , currently 2.41±0.52; Height-SDS: > - 2 SDS, currently 0.80±1.18; | |
| Obese Exercise Group<br>Obese children will engage in increased physical activity (one to two lessons per week) at 40-60 and 60-80% of maximal exercise capacity (n=50 each anticipated). Within the frame of the study we will assess the effect of the exercise on cardiovascular outcomes. | |
| Classical Lifestyle Intervention<br>Obese children will receive a classical lifestyle intervention, including dietary, activity and psychosocial counselling (n=50 anticipated). Within the frame of the study we will assess the effect of the exercise on cardiovascular outcomes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular dysfunction | Assessment of endothelial function, carotid intima media thickness, blood pressure, echocardiography, exercise capacity, insulin sensitivity by oGTT, serum lipids | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, children, obesity, cardiovascular dysfunction, carotid intima media thickness, blood pressure, oral glucose tolerance test