Longitudinal Assessment of Cardiovascular and Metabolic Parameters in Obese and Lean Children
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|ClinicalTrials.gov Identifier: NCT01605123|
Recruitment Status : Recruiting
First Posted : May 24, 2012
Last Update Posted : February 28, 2017
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Leipzig Artherobesity Childhood Cohort|
|Actual Study Start Date :||April 2007|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
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.
- cardiovascular dysfunction [ Time Frame: 7 years ]Assessment of endothelial function, carotid intima media thickness, blood pressure, echocardiography, exercise capacity, insulin sensitivity by oGTT, serum lipids
Biospecimen Retention: Samples With DNA
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): NCT01605123
|Contact: Antje Koerner, MD||Antje.Körner@medizin.uni-leipzig.de|
|Contact: Kathrin Scheuermann||Kathrin.Scheuermann@medizin.uni-leipzig.de|
|LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig||Recruiting|
|Leipzig, Saxony, Germany, 04103|
|Contact: Wieland Kiess, Prof. MD firstname.lastname@example.org|
|Contact: LIFE Child email@example.com|
|Principal Investigator: Wieland Kiess, Prof., MD|
|Principal Investigator: Antje Körner, Prof.,MD|
|University Leipzig Medical Center, Department of Women and Child Health, Center for Pediatric Research||Recruiting|
|Leipzig, Saxony, Germany, 04103|
|Contact: Wieland Kiess, MD Wieland.Kiess@medizin.uni-leipzig.de|
|Principal Investigator: Körner Antje, MD|
|Principal Investigator:||Antje Körner, MD||University of Leipzig|