Metabolic Syndrome and Gen-polymorphs Influence on Weightloss Among Children in Treatment for Overweight

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hyperlipidemia, Insulin Sensitivity, Childhood Obesity, NAFLD (Non-alcoholic Fatty Liver Disease), Hypertension

Intervention / Treatment
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* Other: Chronic care multidisciplinary intervention of childhood obesity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weightloss |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs | Nafld measured by Magnet resonance spectroscopy. Sequencing of MC4R | 1 Year |