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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by University of Leipzig.
Recruitment status was:  Active, not recruiting
German Research Foundation
Information provided by (Responsible Party):
Antje Koerner, Prof. Dr. med., University of Leipzig Identifier:
First received: May 22, 2012
Last updated: June 12, 2014
Last verified: June 2014

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 Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Leipzig Artherobesity Childhood Cohort

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • 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
Serum samples, samples from oral glucose tolerance tests (oGTT), EDTA/DNA samples, primary cells (endothelial progenitor cells), peripheral blood mononuclear cells), urine

Estimated Enrollment: 200
Study Start Date: April 2007
Lean children
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
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.


Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obese children from our out-patient department in Leipzig, Germany Lean children community-based from Leipzig

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01605123

University Leipzig Medical Center, Department of Women and Child Health, Center for Pediatric Research
Leipzig, Saxony, Germany, 04103
Sponsors and Collaborators
University of Leipzig
German Research Foundation
Principal Investigator: Antje Körner, MD University of Leipzig
  More Information

Additional Information:

Responsible Party: Antje Koerner, Prof. Dr. med., Prof. Dr. med., University of Leipzig Identifier: NCT01605123     History of Changes
Other Study ID Numbers: KFO152/SFB1052-C5 
Study First Received: May 22, 2012
Last Updated: June 12, 2014

Keywords provided by University of Leipzig:
endothelial function
cardiovascular dysfunction
carotid intima media thickness
blood pressure
oral glucose tolerance test processed this record on February 24, 2017