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

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Antje Koerner, Prof. Dr. med., University of Leipzig
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: February 24, 2017
Last verified: February 2017
  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

Further study details as provided by Antje Koerner, Prof. Dr. med., 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
Actual Study Start Date: April 2007
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
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   (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Antje Koerner, MD Antje.Körner@medizin.uni-leipzig.de
Contact: Kathrin Scheuermann Kathrin.Scheuermann@medizin.uni-leipzig.de

Locations
Germany
LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig Recruiting
Leipzig, Saxony, Germany, 04103
Contact: Wieland Kiess, Prof. MD       wieland.kiess@medizin.uni-leipzig.de   
Contact: LIFE Child       contact@life.uni-leipzig.de   
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         
Sponsors and Collaborators
University of Leipzig
German Research Foundation
Investigators
Principal Investigator: Antje Körner, MD University of Leipzig
  More Information

Additional Information:
Publications:
Felix JF, Bradfield JP, Monnereau C, van der Valk RJ, Stergiakouli E, Chesi A, Gaillard R, Feenstra B, Thiering E, Kreiner-Møller E, Mahajan A, Pitkänen N, Joro R, Cavadino A, Huikari V, Franks S, Groen-Blokhuis MM, Cousminer DL, Marsh JA, Lehtimäki T, Curtin JA, Vioque J, Ahluwalia TS, Myhre R, Price TS, Vilor-Tejedor N, Yengo L, Grarup N, Ntalla I, Ang W, Atalay M, Bisgaard H, Blakemore AI, Bonnefond A, Carstensen L; Bone Mineral Density in Childhood Study (BMDCS); Early Genetics and Lifecourse Epidemiology (EAGLE) consortium, Eriksson J, Flexeder C, Franke L, Geller F, Geserick M, Hartikainen AL, Haworth CM, Hirschhorn JN, Hofman A, Holm JC, Horikoshi M, Hottenga JJ, Huang J, Kadarmideen HN, Kähönen M, Kiess W, Lakka HM, Lakka TA, Lewin AM, Liang L, Lyytikäinen LP, Ma B, Magnus P, McCormack SE, McMahon G, Mentch FD, Middeldorp CM, Murray CS, Pahkala K, Pers TH, Pfäffle R, Postma DS, Power C, Simpson A, Sengpiel V, Tiesler CM, Torrent M, Uitterlinden AG, van Meurs JB, Vinding R, Waage J, Wardle J, Zeggini E, Zemel BS, Dedoussis GV, Pedersen O, Froguel P, Sunyer J, Plomin R, Jacobsson B, Hansen T, Gonzalez JR, Custovic A, Raitakari OT, Pennell CE, Widén E, Boomsma DI, Koppelman GH, Sebert S, Järvelin MR, Hyppönen E, McCarthy MI, Lindi V, Harri N, Körner A, Bønnelykke K, Heinrich J, Melbye M, Rivadeneira F, Hakonarson H, Ring SM, Smith GD, Sørensen TI, Timpson NJ, Grant SF, Jaddoe VW; Early Growth Genetics (EGG) Consortium; Bone Mineral Density in Childhood Study BMDCS. Genome-wide association analysis identifies three new susceptibility loci for childhood body mass index. Hum Mol Genet. 2016 Jan 15;25(2):389-403. doi: 10.1093/hmg/ddv472. Epub 2015 Nov 24.

Responsible Party: Antje Koerner, Prof. Dr. med., Prof. Dr. med., 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: February 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Antje Koerner, Prof. Dr. med., University of Leipzig:
endothelial function
children
obesity
cardiovascular dysfunction
carotid intima media thickness
blood pressure
oral glucose tolerance test

ClinicalTrials.gov processed this record on July 24, 2017