Metabolic Syndrome and Gen-polymorphs Influence on Weightloss Among Children in Treatment for Overweight
|ClinicalTrials.gov Identifier: NCT00823277|
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : May 1, 2014
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.
|Condition or disease||Intervention/treatment|
|Childhood Obesity NAFLD (Non-alcoholic Fatty Liver Disease) Hypertension Hyperlipidemia Insulin Sensitivity||Other: Chronic care multidisciplinary intervention of childhood obesity|
|Study Type :||Observational|
|Actual Enrollment :||517 participants|
|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 Start Date :||January 2009|
|Primary Completion Date :||August 2012|
|Study Completion Date :||August 2012|
Overweight and obese Children (BMI SDS > 90th percentile according to Danish BMI sheets) 5-20 Years of age. Recruited from the Paediatric department, University Hospital Holbaek, Region Zealand, Denmark, University of Copenhagen
Other: Chronic care multidisciplinary intervention of childhood obesity
Overweight and obese Children, 5-20 Years old, followed by Paediatricians and other Health Personals (multidisciplinary team). Included at their first visit in the clinic (baseline)and follow-up after ~ 1 Year.
- weightloss [ Time Frame: 1 Year ]
- NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs [ Time Frame: 1 Year ]Nafld measured by Magnet resonance spectroscopy. Sequencing of MC4R
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823277
|The Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek, Region Zealand, University of Copenhagen|
|Holbaek, Denmark, 4300|
|Principal Investigator:||Dorthe S. Bille, MD||Paediatric department, University Hospital Holbaek, Region Zealand, University of Copenhagen, Denmark|