Clinical trial NCT01605123: Longitudinal Assessment of Cardiovascular and Metabolic Parameters in Obese and Lean Children
Official title: Leipzig Artherobesity Childhood Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: endothelial function
children
obesity
cardiovascular dysfunction
carotid intima media thickness
blood pressure
oral glucose tolerance test
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2012-05-24
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese children from our out-patient department in Leipzig, Germany Lean children community-based from Leipzig

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: cardiovascular dysfunction
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig
state: Saxony
city: Leipzig
country: Germany
facility: University Leipzig Medical Center, Department of Women and Child Health, Center for Pediatric Research
state: Saxony
Study officials:
affiliation: University of Leipzig
name: Antje Körner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korner 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. doi: 10.1203/01.pdr.0000262638.48304.ef.
citation: Landgraf K, Friebe D, Ullrich T, Kratzsch J, Dittrich K, Herberth G, Adams V, Kiess W, Erbs S, Korner 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.
citation: 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.
citation: Friebe D, Neef M, Kratzsch J, Erbs S, Dittrich K, Garten A, Petzold-Quinque S, Bluher S, Reinehr T, Stumvoll M, Bluher M, Kiess W, Korner 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.
citation: Friebe D, Neef M, Erbs S, Dittrich K, Kratzsch J, Kovacs P, Bluher M, Kiess W, Korner 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.
citation: Korner A, Neef M, Friebe D, Erbs S, Kratzsch J, Dittrich K, Bluher S, Kapellen TM, Kovacs P, Stumvoll M, Bluher 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.
citation: Ehehalt S, Wiegand S, Korner A, Schweizer R, Liesenkotter 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.
citation: Ehehalt S, Wiegand S, Korner A, Schweizer R, Liesenkotter 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. 2017 Dec;18(8):734-741. doi: 10.1111/pedi.12461. Epub 2016 Nov 22.
citation: Schreier M, Schwartze JT, Landgraf K, Scheuermann K, Erbs S, Herberth G, Pospisilik JA, Kratzsch J, Kiess W, Korner A. Osteopontin is BMI-independently Related to Early Endothelial Dysfunction in Children. J Clin Endocrinol Metab. 2016 Nov;101(11):4161-4169. doi: 10.1210/jc.2016-2238. Epub 2016 Aug 29.
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citation: Breitling C, Gross A, Buttner P, Weise S, Schleinitz D, Kiess W, Scholz M, Kovacs P, Korner 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.
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citation: Loffler D, Muller U, Scheuermann K, Friebe D, Gesing J, Bielitz J, Erbs S, Landgraf K, Wagner IV, Kiess W, Korner 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.
citation: Mangner N, Scheuermann K, Winzer E, Wagner I, Hoellriegel R, Sandri M, Zimmer M, Mende M, Linke A, Kiess W, Schuler G, Korner 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.
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