Longitudinal Assessment of Cardiovascular and Metabolic Parameters in Obese and Lean Children
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Leipzig Artherobesity Childhood Cohort|
- cardiovascular dysfunction [ Time Frame: 7 years ] [ Designated as safety issue: No ]Assessment of endothelial function, carotid intima media thickness, blood pressure, echocardiography, exercise capacity, insulin sensitivity by oGTT, serum lipids
Biospecimen Retention: Samples With DNA
Serum samples, samples from oral glucose tolerance tests (oGTT), EDTA/DNA samples, primary cells (endothelial progenitor cells), peripheral blood mononuclear cells), urine
|Study Start Date:||April 2007|
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;
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
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605123
|University Leipzig Medical Center, Department of Women and Child Health, Center for Pediatric Research|
|Leipzig, Saxony, Germany, 04103|
|Principal Investigator:||Antje Körner, MD||University of Leipzig|