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

Completed

• Conditions: Hyperlipidemia; NAFLD (Non-alcoholic Fatty Liver Disease); Childhood Obesity; Hypertension; Insulin Sensitivity
• Interventions: Other: Chronic care multidisciplinary intervention of childhood obesity

• Registration Number: NCT00823277
• Lead Sponsor: Holbaek Sygehus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 517

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Chronic care multidisciplinary intervention of childhood obesity	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

Primary Outcome Measures

Name	Time	Method
weightloss	1 Year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek, Region Zealand, University of Copenhagen; 🇩🇰 Holbaek, Denmark