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The Danish Childhood Obesity Biobank

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Roskilde County Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Holbaek Sygehus
University of Copenhagen
Steno Diabetes Center
Information provided by:
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT00928473
First received: June 25, 2009
Last updated: September 10, 2009
Last verified: September 2009

June 25, 2009
September 10, 2009
January 2009
January 2009   (final data collection date for primary outcome measure)
Weightloss, changes in blood parameters and in fatty liver developement. [ Time Frame: continuously ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00928473 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Danish Childhood Obesity Biobank
The Danish Childhood Obesity Biobank

The Danish Childhood Obesity Biobank collects blood from obese and normal weighted children to produce a scientific platform for research in obesity.

2500 obese children will be included from the The Children's Obesity Clinic, Paediatric department, Holbaek Hospital. As a control group 2500 normal weighted children will be included from the schools in Region Zealand, Denmark.

Fasting blood samples are taking and stored in a freezer at -80 degreases celsius.The blood samples will be analysed for metabolic parameters, insulin, glucose, liver and kidney parameters, hgb.

Furthermore, genetic analyses will be made at the Steno Diabetes Center. Height, weight, waist and hip circumferences are measured. The children are 5-18 years old.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Weight Loss
  • Obesity
  • Metabolic Syndrome
  • NAFLD, Non-alcoholic Fatty Liver Disease
  • Cardiovascular Diseases
Behavioral: Weightloss treatment program
The obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI.
Experimental: Lifestyle counseling
The obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI.
Intervention: Behavioral: Weightloss treatment program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
January 2012
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 5- 22 Years old
  • Adipose, BMI > 97 % percentile

Exclusion Criteria:

  • Drop-outs
Both
5 Years to 22 Years
No
Contact: Jens-Christian Holm, Ph.d., MD jhom@regionsjaelland.dk
Denmark
 
NCT00928473
250609
Yes
Jens-Christian Holm, The Children's Obesity Clinic, Paediatric Department, University Hosp. Holbaek, Region Zealand, Denmark, University of Copenhagen
Roskilde County Hospital
  • Holbaek Sygehus
  • University of Copenhagen
  • Steno Diabetes Center
Study Chair: Jens-Christian Holm, Ph.d., MD The Children's Obesity Clinic and The Danish Childhood Obesity Biobank
Roskilde County Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP