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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Antje Koerner, Prof. Dr. med., University of Leipzig
ClinicalTrials.gov Identifier:
NCT01605123
First received: May 22, 2012
Last updated: June 12, 2014
Last verified: June 2014

May 22, 2012
June 12, 2014
April 2007
Not Provided
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
Same as current
Complete list of historical versions of study NCT01605123 on ClinicalTrials.gov Archive Site
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Longitudinal Assessment of Cardiovascular and Metabolic Parameters in Obese and Lean Children
Leipzig Artherobesity Childhood Cohort

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

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

Non-Probability Sample

Obese children from our out-patient department in Leipzig, Germany Lean children community-based from Leipzig

Obesity
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  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
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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
Both
6 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01605123
KFO152/SFB1052-C5
No
Antje Koerner, Prof. Dr. med., University of Leipzig
University of Leipzig
German Research Foundation
Principal Investigator: Antje Körner, MD University of Leipzig
University of Leipzig
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP