Clinical trial NCT00823277: Metabolic Syndrome and Gen-polymorphs Influence on Weightloss Among Children in Treatment for Overweight
Official title: Indicators for the Metabolic Syndrome as Well as the Influence of Different Gen-polymorphs on Weightloss and the Maintenance of Lower Weight Among Children in Treatment for Overweight
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
NAFLD (Non-alcoholic Fatty Liver Disease)
Hypertension
Hyperlipidemia
Insulin Sensitivity
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Hagedorn Research Institute
name: The Novo Nordisk Foundation Center for Basic Metabolic Research
name: Herlev Hospital
First posted: 2009-01-15
Enrollment: 517
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese Children. 5-20 Years old. Paediatric Department, University Hospital Holbaek,Region Zealand, University of Copenhagen, Denmark

Brief summary: Definition:

the overall objective is to examine childhood obesity with focus on NAFLD and its treatment. Further, we aimed to investigate the impact of genetic variation on obesity.

The specific aims are to;

* describe the degree of NAFLD among overweight and obese, Danish children. (hypothesis; the degree for pediatric NAFLD among Danish Children was equal that found in other Caucasian paediatric study populations).
* investigate the effect of a multidisciplinary intervention treatment of 1 year on liver fat content.

(hypothesis; the intervention could reduce the liver fat percentage and a reduction in BMI SDS would associate with a reduction in liver fat content) - Analyze changes in liver fat content in relation to changes in levels of fasting blood variables to see if any of them could be used as a clinical tool for monitoring hepatic steatosis in the clinic.

(hypothesis; serum aminotransferases (separately and their ratio, respectively), serum insulin, and HOMA-IR could predict improvement in liver fat content

- Investigate the association between genetic variants and obesity.


Eligibility criteria: Inclusion Criteria:

* 5- 20 Years old.
* Adipose. BMI \> 90 % percentile
* New patient in the Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek,Region Zealand, Denmark
* Informed Consent

Exclusion Criteria:

* Drop-outs

Primary outcomes:
measure: weightloss
timeFrame: 1 Year
Secondary outcomes:
measure: NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs
timeFrame: 1 Year
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: The Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek, Region Zealand, University of Copenhagen
Study officials:
affiliation: Paediatric department, University Hospital Holbaek, Region Zealand, University of Copenhagen, Denmark
name: Dorthe S. Bille, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chabanova E, Bille DS, Thisted E, Holm JC, Thomsen HS. MR spectroscopy of liver in overweight children and adolescents: investigation of (1)H T(2) relaxation times at 3T. Eur J Radiol. 2012 May;81(5):811-4. doi: 10.1016/j.ejrad.2011.02.017. Epub 2011 Mar 4.
citation: Chabanova E, Bille DS, Thisted E, Holm JC, Thomsen HS. (1)H MRS assessment of hepatic steatosis in overweight children and adolescents: comparison between 3T and open 1T MR-systems. Abdom Imaging. 2013 Apr;38(2):315-9. doi: 10.1007/s00261-012-9930-2.
citation: Bille DS, Chabanova E, Gamborg M, Fonvig CE, Nielsen TR, Thisted E, Thomsen HS, Holm JC. Liver fat content investigated by magnetic resonance spectroscopy in obese children and youths included in multidisciplinary treatment. Clin Obes. 2012 Feb;2(1-2):41-9. doi: 10.1111/j.1758-8111.2012.00038.x. Epub 2012 Apr 24.