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

This study is currently recruiting participants.
Verified February 2017 by Antje Koerner, Prof. Dr. med., University of Leipzig
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605123
First Posted: May 24, 2012
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Antje Koerner, Prof. Dr. med., University of Leipzig
  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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Landgraf K, Friebe D, Ullrich T, Kratzsch J, Dittrich K, Herberth G, Adams V, Kiess W, Erbs S, Körner A. Chemerin as a mediator between obesity and vascular inflammation in children. J Clin Endocrinol Metab. 2012 Apr;97(4):E556-64. doi: 10.1210/jc.2011-2937. Epub 2012 Mar 21.
Raschpichler MC, Sorge I, Hirsch W, Mende M, Sergeyev E, Kruber D, Koerner A, Schick F. Evaluating childhood obesity: magnetic resonance-based quantification of abdominal adipose tissue and liver fat in children. Rofo. 2012 Apr;184(4):324-32. doi: 10.1055/s-0031-1299094. Epub 2012 Feb 9.
Friebe D, Neef M, Kratzsch J, Erbs S, Dittrich K, Garten A, Petzold-Quinque S, Blüher S, Reinehr T, Stumvoll M, Blüher M, Kiess W, Körner A. Leucocytes are a major source of circulating nicotinamide phosphoribosyltransferase (NAMPT)/pre-B cell colony (PBEF)/visfatin linking obesity and inflammation in humans. Diabetologia. 2011 May;54(5):1200-11. doi: 10.1007/s00125-010-2042-z. Epub 2011 Feb 6.
Friebe D, Neef M, Erbs S, Dittrich K, Kratzsch J, Kovacs P, Blüher M, Kiess W, Körner A. Retinol binding protein 4 (RBP4) is primarily associated with adipose tissue mass in children. Int J Pediatr Obes. 2011 Jun;6(2-2):e345-52. doi: 10.3109/17477166.2010.491228. Epub 2010 Oct 15.
Körner A, Neef M, Friebe D, Erbs S, Kratzsch J, Dittrich K, Blüher S, Kapellen TM, Kovacs P, Stumvoll M, Blüher M, Kiess W. Vaspin is related to gender, puberty and deteriorating insulin sensitivity in children. Int J Obes (Lond). 2011 Apr;35(4):578-86. doi: 10.1038/ijo.2010.196. Epub 2010 Sep 21.
Ehehalt S, Wiegand S, Körner A, Schweizer R, Liesenkötter KP, Partsch CJ, Blumenstock G, Spielau U, Denzer C, Ranke MB, Neu A, Binder G, Wabitsch M, Kiess W, Reinehr T. Diabetes screening in overweight and obese children and adolescents: choosing the right test. Eur J Pediatr. 2017 Jan;176(1):89-97. doi: 10.1007/s00431-016-2807-6. Epub 2016 Nov 25.
Ehehalt S, Wiegand S, Körner A, Schweizer R, Liesenkötter KP, Partsch CJ, Blumenstock G, Spielau U, Denzer C, Ranke MB, Neu A, Binder G, Wabitsch M, Kiess W, Reinehr T. Low association between fasting and OGTT stimulated glucose levels with HbA1c in overweight children and adolescents. Pediatr Diabetes. 2016 Nov 22. doi: 10.1111/pedi.12461. [Epub ahead of print]
Schreier M, Schwartze JT, Landgraf K, Scheuermann K, Erbs S, Herberth G, Pospisilik JA, Kratzsch J, Kiess W, Körner A. Osteopontin is BMI-independently Related to Early Endothelial Dysfunction in Children. J Clin Endocrinol Metab. 2016 Nov;101(11):4161-4169. Epub 2016 Aug 29.
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.
Breitling C, Gross A, Büttner P, Weise S, Schleinitz D, Kiess W, Scholz M, Kovacs P, Körner A. Genetic Contribution of Variants near SORT1 and APOE on LDL Cholesterol Independent of Obesity in Children. PLoS One. 2015 Sep 16;10(9):e0138064. doi: 10.1371/journal.pone.0138064. eCollection 2015.
Qi Q, Downer MK, Kilpeläinen TO, Taal HR, Barton SJ, Ntalla I, Standl M, Boraska V, Huikari V, Kiefte-de Jong JC, Körner A, Lakka TA, Liu G, Magnusson J, Okuda M, Raitakari O, Richmond R, Scott RA, Bailey ME, Scheuermann K, Holloway JW, Inskip H, Isasi CR, Mossavar-Rahmani Y, Jaddoe VW, Laitinen J, Lindi V, Melén E, Pitsiladis Y, Pitkänen N, Snieder H, Heinrich J, Timpson NJ, Wang T, Yuji H, Zeggini E, Dedoussis GV, Kaplan RC, Wylie-Rosett J, Loos RJ, Hu FB, Qi L. Dietary Intake, FTO Genetic Variants, and Adiposity: A Combined Analysis of Over 16,000 Children and Adolescents. Diabetes. 2015 Jul;64(7):2467-76. doi: 10.2337/db14-1629. Epub 2015 Feb 26.
Löffler D, Müller U, Scheuermann K, Friebe D, Gesing J, Bielitz J, Erbs S, Landgraf K, Wagner IV, Kiess W, Körner A. Serum irisin levels are regulated by acute strenuous exercise. J Clin Endocrinol Metab. 2015 Apr;100(4):1289-99. doi: 10.1210/jc.2014-2932. Epub 2015 Jan 27.
Mangner N, Scheuermann K, Winzer E, Wagner I, Hoellriegel R, Sandri M, Zimmer M, Mende M, Linke A, Kiess W, Schuler G, Körner A, Erbs S. Childhood obesity: impact on cardiac geometry and function. JACC Cardiovasc Imaging. 2014 Dec;7(12):1198-205. doi: 10.1016/j.jcmg.2014.08.006. Epub 2014 Oct 8.
Körner A, Wiegand S, Hungele A, Tuschy S, Otto KP, l'Allemand-Jander D, Widhalm K, Kiess W, Holl RW; APV initiative; German Competence Net Obesity. Longitudinal multicenter analysis on the course of glucose metabolism in obese children. Int J Obes (Lond). 2013 Jul;37(7):931-6. doi: 10.1038/ijo.2012.163. Epub 2012 Oct 2.
Ichimura A, Hirasawa A, Poulain-Godefroy O, Bonnefond A, Hara T, Yengo L, Kimura I, Leloire A, Liu N, Iida K, Choquet H, Besnard P, Lecoeur C, Vivequin S, Ayukawa K, Takeuchi M, Ozawa K, Tauber M, Maffeis C, Morandi A, Buzzetti R, Elliott P, Pouta A, Jarvelin MR, Körner A, Kiess W, Pigeyre M, Caiazzo R, Van Hul W, Van Gaal L, Horber F, Balkau B, Lévy-Marchal C, Rouskas K, Kouvatsi A, Hebebrand J, Hinney A, Scherag A, Pattou F, Meyre D, Koshimizu TA, Wolowczuk I, Tsujimoto G, Froguel P. Dysfunction of lipid sensor GPR120 leads to obesity in both mouse and human. Nature. 2012 Feb 19;483(7389):350-4. doi: 10.1038/nature10798.
Körner A, Kratzsch J, Gausche R, Schaab M, Erbs S, Kiess W. New predictors of the metabolic syndrome in children--role of adipocytokines. Pediatr Res. 2007 Jun;61(6):640-5. Review.

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
First Submitted: May 22, 2012
First Posted: May 24, 2012
Last Update Posted: February 28, 2017
Last Verified: February 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


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