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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823277
First Posted: January 15, 2009
Last Update Posted: May 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Holbaek Sygehus
University of Copenhagen
Hagedorn Research Institute
The Novo Nordisk Foundation Center for Basic Metabolic Research
The Diagnostic Radiology Department, Herlev Hospital
Information provided by (Responsible Party):
Dixi Louise Strand, Roskilde County Hospital
January 14, 2009
January 15, 2009
May 1, 2014
January 2009
August 2012   (Final data collection date for primary outcome measure)
weightloss [ Time Frame: 1 Year ]
Weigthloss. [ Time Frame: 1 Year ]
Complete list of historical versions of study NCT00823277 on ClinicalTrials.gov Archive Site
NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs [ Time Frame: 1 Year ]
Nafld measured by Magnet resonance spectroscopy. Sequencing of MC4R
Bloodpresure. NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs [ Time Frame: 1 Year ]
Not Provided
Not Provided
 
Metabolic Syndrome and Gen-polymorphs Influence on Weightloss Among Children in Treatment for Overweight
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

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood samples of Whoole Blood.
Non-Probability Sample
Overweight and obese Children. 5-20 Years old. Paediatric Department, University Hospital Holbaek,Region Zealand, University of Copenhagen, Denmark
  • Childhood Obesity
  • NAFLD (Non-alcoholic Fatty Liver Disease)
  • Hypertension
  • Hyperlipidemia
  • Insulin Sensitivity
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.
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
Intervention: Other: Chronic care multidisciplinary intervention of childhood obesity

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
517
August 2012
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 20 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00823277
130109
SJ-98
No
Not Provided
Not Provided
Dixi Louise Strand, Roskilde County Hospital
Zealand University Hospital
  • Holbaek Sygehus
  • University of Copenhagen
  • Hagedorn Research Institute
  • The Novo Nordisk Foundation Center for Basic Metabolic Research
  • The Diagnostic Radiology Department, Herlev Hospital
Principal Investigator: Dorthe S. Bille, MD Paediatric department, University Hospital Holbaek, Region Zealand, University of Copenhagen, Denmark
Zealand University Hospital
April 2014