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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):
Prof. Dr. Antje Koerner, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01605123
First received: May 22, 2012
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Obesity

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • 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, EDTA/DNA samples, primary cells (endothelial progenitor cells), peripheral blood mononuclear cells), urine


Estimated Enrollment: 200
Study Start Date: April 2007
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605123

Locations
Germany
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
Investigators
Principal Investigator: Antje Körner, MD University of Leipzig
  More Information

Additional Information:
KFO152 Atherobesity Homepage  This link exits the ClinicalTrials.gov site
University Leipzig Medical Center, Department of Women and Child Health, Hospital for Children and Adolescents Homepage  This link exits the ClinicalTrials.gov site
University Leipzig Medical Center Homepage  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Prof. Dr. Antje Koerner, Prof. Dr., University of Leipzig
ClinicalTrials.gov Identifier: NCT01605123     History of Changes
Other Study ID Numbers: KFO152/SFB1052-C5
Study First Received: May 22, 2012
Last Updated: May 23, 2012
Health Authority: Germany: Ethical Commitee, University Leipzig

Keywords provided by University of Leipzig:
endothelial function
children
obesity
cardiovascular dysfunction
 carotid intima media thickness
blood pressure
oral glucose tolerance test

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013