Clinical trial NCT00928473: The Danish Childhood Obesity Biobank
Official title: The Danish Childhood Obesity Biobank
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Metabolic Disease
NAFLD, Non-alcoholic Fatty Liver Disease
Cardiovascular Diseases
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Steno Diabetes Center Copenhagen
name: Holbaek Sygehus
First posted: 2009-06-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Danish Childhood Obesity Biobank aims to produce a scientific platform for research in obesity: Bio-clinical data are collected from two cohorts - an obesity clinic cohort and a population-based cohort. The biobank thus facilitates translation between research and clinical practice of obesity treatment and related complications.

Detailed description: The Danish Childhood Obesity Biobank collects data from two cohorts - an obesity clinic cohort and a population-based cohort, of which the latter functions as a reference group.

The biobank continuously and longitudinally includes clinical data and biological samples from children and adolescents in obesity treatment. The population-based cohort has been recruited in a cross-sectional manner from Danish schools, high schools, and dentistries.

Data included in the biobank include venous blood samples, stool, urine, saliva, anthropometrics, body composition by dual-energy X-ray absorptiometry, magnetic resonance imaging and spectroscopy, and genetic markers among others. The data are stored in a central secured electronic database and biological materials are stored in -80-degree Celsius freezers until analyses.

To date, the Danish Childhood Obesity Biobank have included data from more than 5250 children, adolescents and adults from the obesity clinic cohort and more than 4200 from the population-based cohort.

Eligibility criteria: Inclusion Criteria:

* 2- 100 Years old
* Adipose, BMI \> 90 % percentile

Primary outcomes:
measure: Weightloss, changes in blood parameters and in fatty liver developement.
timeFrame: continuously
Secondary outcomes:
Other outcomes:
Locations:
city: Holbæk
country: Denmark
facility: The Children's Obesity Clinic, Paediatric department, University Hospital Holbæk, Region Zealand
Study officials:
affiliation: The Children's Obesity Clinic and The Danish Childhood Obesity Biobank
name: Jens-Christian Holm, Ph.d., MD
role: STUDY_CHAIR
References:
citation: Johansen MJ, Vonsild Lund MA, Angquist L, Fonvig CE, Holm LA, Chabanova E, Thomsen HS, Hansen T, Holm JC. Possible prediction of obesity-related liver disease in children and adolescents using indices of body composition. Pediatr Obes. 2022 Oct;17(10):e12947. doi: 10.1111/ijpo.12947. Epub 2022 Jun 21.
citation: Frithioff-Bojsoe C, Lund MAV, Lausten-Thomsen U, Fonvig CE, Lankjaer IOJ, Hansen T, Hansen T, Baker JL, Holm JC. Early detection of childhood overweight and related complications in a Danish population-based cohort aged 2-8 years. Obes Res Clin Pract. 2022 May-Jun;16(3):228-234. doi: 10.1016/j.orcp.2022.04.001. Epub 2022 May 3.
citation: Stinson SE, Jonsson AE, de Retana Alzola IF, Lund MAV, Frithioff-Bojsoe C, Aas Holm L, Fonvig CE, Pedersen O, Angquist L, Sorensen TIA, Holst JJ, Christiansen M, Holm JC, Hartmann B, Hansen T. Hyperglucagonemia in Pediatric Adiposity Associates With Cardiometabolic Risk Factors but Not Hyperglycemia. J Clin Endocrinol Metab. 2022 May 17;107(6):1569-1576. doi: 10.1210/clinem/dgac108.
citation: Stinson SE, Jonsson AE, Lund MAV, Frithioff-Bojsoe C, Aas Holm L, Pedersen O, Angquist L, Sorensen TIA, Holst JJ, Christiansen M, Holm JC, Hartmann B, Hansen T. Fasting Plasma GLP-1 Is Associated With Overweight/Obesity and Cardiometabolic Risk Factors in Children and Adolescents. J Clin Endocrinol Metab. 2021 May 13;106(6):1718-1727. doi: 10.1210/clinem/dgab098.
citation: Lund MAV, Thostrup AH, Frithioff-Bojsoe C, Lausten-Thomsen U, Hedley PL, Pedersen O, Christiansen M, Hansen T, Holm JC. Low-grade inflammation independently associates with cardiometabolic risk in children with overweight/obesity. Nutr Metab Cardiovasc Dis. 2020 Aug 28;30(9):1544-1553. doi: 10.1016/j.numecd.2020.04.024. Epub 2020 May 5.
citation: Jors A, Lund MAV, Jespersen T, Hansen T, Poulsen HE, Holm JC. Urinary markers of nucleic acid oxidation increase with age, obesity and insulin resistance in Danish children and adolescents. Free Radic Biol Med. 2020 Aug 1;155:81-86. doi: 10.1016/j.freeradbiomed.2020.05.009. Epub 2020 May 25.
citation: Frithioff-Bojsoe C, Lund MAV, Lausten-Thomsen U, Hedley PL, Pedersen O, Christiansen M, Baker JL, Hansen T, Holm JC. Leptin, adiponectin, and their ratio as markers of insulin resistance and cardiometabolic risk in childhood obesity. Pediatr Diabetes. 2020 Mar;21(2):194-202. doi: 10.1111/pedi.12964. Epub 2019 Dec 26.
citation: Johansen MJ, Gade J, Stender S, Frithioff-Bojsoe C, Lund MAV, Chabanova E, Thomsen HS, Pedersen O, Fonvig CE, Hansen T, Holm JC. The Effect of Overweight and Obesity on Liver Biochemical Markers in Children and Adolescents. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz010. doi: 10.1210/clinem/dgz010.
citation: Viitasalo A, Schnurr TM, Pitkanen N, Hollensted M, Nielsen TRH, Pahkala K, Atalay M, Lind MV, Heikkinen S, Frithioff-Bojsoe C, Fonvig CE, Grarup N, Kahonen M, Carrasquilla GD, Larnkjaer A, Pedersen O, Michaelsen KF, Lakka TA, Holm JC, Lehtimaki T, Raitakari O, Hansen T, Kilpelainen TO. Abdominal adiposity and cardiometabolic risk factors in children and adolescents: a Mendelian randomization analysis. Am J Clin Nutr. 2019 Nov 1;110(5):1079-1087. doi: 10.1093/ajcn/nqz187.
citation: Hollensted M, Fogh M, Schnurr TM, Kloppenborg JT, Have CT, Ruest Haarmark Nielsen T, Rask J, Asp Vonsild Lund M, Frithioff-Bojsoe C, Ostergaard Johansen M, Vincent Rosenbaum Appel E, Mahendran Y, Grarup N, Kadarmideen HN, Pedersen O, Holm JC, Hansen T. Genetic Susceptibility for Childhood BMI has no Impact on Weight Loss Following Lifestyle Intervention in Danish Children. Obesity (Silver Spring). 2018 Dec;26(12):1915-1922. doi: 10.1002/oby.22308.
citation: Fonvig CE, Hamann SA, Nielsen TRH, Johansen MO, Gronbaek HN, Mollerup PM, Holm JC. Subjective evaluation of psychosocial well-being in children and youths with overweight or obesity: the impact of multidisciplinary obesity treatment. Qual Life Res. 2017 Dec;26(12):3279-3288. doi: 10.1007/s11136-017-1667-5. Epub 2017 Jul 31.
citation: Nielsen TRH, Lausten-Thomsen U, Fonvig CE, Bojsoe C, Pedersen L, Bratholm PS, Hansen T, Pedersen O, Holm JC. Dyslipidemia and reference values for fasting plasma lipid concentrations in Danish/North-European White children and adolescents. BMC Pediatr. 2017 Apr 28;17(1):116. doi: 10.1186/s12887-017-0868-y.
citation: Rischel HE, Nielsen LA, Gamborg M, Moller P, Holm JC. Comparison of sensory-specific satiety between normal weight and overweight children. Appetite. 2016 Dec 1;107:486-493. doi: 10.1016/j.appet.2016.08.123. Epub 2016 Sep 1.
citation: Trier C, Dahl M, Stjernholm T, Nielsen TR, Bojsoe C, Fonvig CE, Pedersen O, Hansen T, Holm JC. Effects of a Family-Based Childhood Obesity Treatment Program on Parental Weight Status. PLoS One. 2016 Aug 25;11(8):e0161921. doi: 10.1371/journal.pone.0161921. eCollection 2016.
citation: Fonvig CE, Chabanova E, Ohrt JD, Nielsen LA, Pedersen O, Hansen T, Thomsen HS, Holm JC. Multidisciplinary care of obese children and adolescents for one year reduces ectopic fat content in liver and skeletal muscle. BMC Pediatr. 2015 Dec 30;15:196. doi: 10.1186/s12887-015-0513-6.
citation: Lausten-Thomsen U, Christiansen M, Fonvig CE, Trier C, Pedersen O, Hansen T, Holm JC. Reference values for serum total adiponectin in healthy non-obese children and adolescents. Clin Chim Acta. 2015 Oct 23;450:11-4. doi: 10.1016/j.cca.2015.07.012. Epub 2015 Jul 10.
citation: Hvidt KN, Olsen MH, Ibsen H, Holm JC. Weight reduction and aortic stiffness in obese children and adolescents: a 1-year follow-up study. J Hum Hypertens. 2015 Sep;29(9):535-40. doi: 10.1038/jhh.2014.127. Epub 2015 Jan 15.
citation: Hvidt KN, Olsen MH, Ibsen H, Holm JC. Effect of changes in BMI and waist circumference on ambulatory blood pressure in obese children and adolescents. J Hypertens. 2014 Jul;32(7):1470-7; discussion 1477. doi: 10.1097/HJH.0000000000000188.
citation: Hvidt KN, Olsen MH, Holm JC, Ibsen H. Obese children and adolescents have elevated nighttime blood pressure independent of insulin resistance and arterial stiffness. Am J Hypertens. 2014 Nov;27(11):1408-15. doi: 10.1093/ajh/hpu055. Epub 2014 Apr 9.
citation: Lausten-Thomsen U, Nielsen TR, Thagaard IN, Larsen T, Holm JC. Neonatal anthropometrics and body composition in obese children investigated by dual energy X-ray absorptiometry. Eur J Pediatr. 2014 May;173(5):623-7. doi: 10.1007/s00431-013-2226-x. Epub 2013 Dec 7.
citation: Holm JC, Gamborg M, Neland M, Ward L, Gammeltoft S, Heitmann BL, Sorensen TI, Ibsen KK. Longitudinal changes in blood pressure during weight loss and regain of weight in obese boys and girls. J Hypertens. 2012 Feb;30(2):368-74. doi: 10.1097/HJH.0b013e32834e4a87.