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The Danish Childhood Obesity Biobank

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ClinicalTrials.gov Identifier: NCT00928473
Recruitment Status : Recruiting
First Posted : June 26, 2009
Last Update Posted : June 28, 2017
Sponsor:
Collaborators:
University of Copenhagen
Steno Diabetes Center
Holbaek Sygehus
Information provided by (Responsible Party):
Jens Christian Holm, University of Copenhagen

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

Condition or disease Intervention/treatment Phase
Weight Loss Obesity Metabolic Syndrome NAFLD, Non-alcoholic Fatty Liver Disease Cardiovascular Diseases Behavioral: Weightloss treatment program Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Danish Childhood Obesity Biobank
Study Start Date : January 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
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.
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.



Primary Outcome Measures :
  1. Weightloss, changes in blood parameters and in fatty liver developement. [ Time Frame: continuously ]


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Ages Eligible for Study:   2 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2- 100 Years old
  • Adipose, BMI > 90 % percentile

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928473


Contacts
Contact: Jens-Christian Holm, Ph.d., MD jhom@regionsjaelland.dk

Locations
Denmark
The Children's Obesity Clinic, Paediatric department, University Hospital Holbæk, Region Zealand Recruiting
Holbæk, Denmark, 4300
Contact: Jens-Christian Holm, Ph.d, MD       jhom@regionsjaelland.dk   
Sponsors and Collaborators
Zealand University Hospital
University of Copenhagen
Steno Diabetes Center
Holbaek Sygehus
Investigators
Study Chair: Jens-Christian Holm, Ph.d., MD The Children's Obesity Clinic and The Danish Childhood Obesity Biobank

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jens Christian Holm, MD, PhD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00928473     History of Changes
Other Study ID Numbers: 250609
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Obesity
Cardiovascular Diseases
Weight Loss
Metabolic Syndrome X
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases