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Clinical Trials/NCT00823277
NCT00823277
Completed
Not Applicable

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

Holbaek Sygehus1 site in 1 country517 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Obesity
Sponsor
Holbaek Sygehus
Enrollment
517
Locations
1
Primary Endpoint
weightloss
Status
Completed
Last Updated
2 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
January 2009
End Date
August 2012
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Holbaek Sygehus
Responsible Party
Principal Investigator
Principal Investigator

Jens-Christian Holm

MD, Ph.D.

Zealand University Hospital

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

Outcomes

Primary Outcomes

weightloss

Time Frame: 1 Year

Secondary Outcomes

  • NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs(1 Year)

Study Sites (1)

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