Longitudinal Assessment of Cardiovascular and Metabolic Parameters in Obese and Lean Children
- Conditions
- Obesity
- Registration Number
- NCT01605123
- Lead Sponsor
- University of Leipzig
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- height -2 to +2 SDS
- pubertal stage adequate for age
- no medications
- written consent of guardians and children≥12y
- weight ≥ -2 SDS
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cardiovascular dysfunction 7 years Assessment of endothelial function, carotid intima media thickness, blood pressure, echocardiography, exercise capacity, insulin sensitivity by oGTT, serum lipids
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University Leipzig Medical Center, Department of Women and Child Health, Center for Pediatric Research
🇩🇪Leipzig, Saxony, Germany
LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig
🇩🇪Leipzig, Saxony, Germany