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

Sponsor

Zealand University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00823277

Collaborator

Holbaek Sygehus (Other), University of Copenhagen (Other), Hagedorn Research Institute (Other), The Novo Nordisk Foundation Center for Basic Metabolic Research (Other), Herlev Hospital (Other)

517

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity NAFLD (Non-alcoholic Fatty Liver Disease) Hypertension Hyperlipidemia Insulin Sensitivity	Other: Chronic care multidisciplinary intervention of childhood obesity

Study Design

Study Type:

Observational

Actual Enrollment :

517 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 :

Jan 1, 2009

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
1 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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

weightloss [1 Year]

Secondary Outcome Measures

NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs [1 Year]
Nafld measured by Magnet resonance spectroscopy. Sequencing of MC4R

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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