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The Danish Childhood Obesity Biobank

This study is currently recruiting participants.
Verified June 2017 by Jens Christian Holm, University of Copenhagen
Sponsor:
ClinicalTrials.gov Identifier:
NCT00928473
First Posted: June 26, 2009
Last Update Posted: June 28, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Copenhagen
Steno Diabetes Center
Holbaek Sygehus
Information provided by (Responsible Party):
Jens Christian Holm, University of Copenhagen
June 25, 2009
June 26, 2009
June 28, 2017
January 2009
December 2018   (Final data collection date for primary outcome measure)
Weightloss, changes in blood parameters and in fatty liver developement. [ Time Frame: continuously ]
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, blood pressure, and bodycomposition composition are measured.

The children are 2-22 years old.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (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
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 2- 100 Years old
  • Adipose, BMI > 90 % percentile
Sexes Eligible for Study: All
2 Years to 100 Years   (Child, Adult, Senior)
No
Contact: Jens-Christian Holm, Ph.d., MD jhom@regionsjaelland.dk
Denmark
 
 
NCT00928473
250609
Yes
Not Provided
Not Provided
Jens Christian Holm, University of Copenhagen
Zealand University Hospital
  • University of Copenhagen
  • Steno Diabetes Center
  • Holbaek Sygehus
Study Chair: Jens-Christian Holm, Ph.d., MD The Children's Obesity Clinic and The Danish Childhood Obesity Biobank
Zealand University Hospital
June 2017

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