The Danish Childhood Obesity Biobank

The Danish Childhood Obesity Biobank
This study is currently recruiting participants.
Verified on September 2009 by Roskilde County Hospital

First Received on June 25, 2009.  
Last Updated on September 10, 2009  
History of Changes
Sponsor: Roskilde County Hospital
Collaborators: Holbaek Sygehus
University of Copenhagen
Steno Diabetes Center
Information provided by: Roskilde County Hospital
ClinicalTrials.gov Identifier: NCT00928473
  Purpose

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

Condition Intervention
Weight Loss
Obesity
Metabolic Syndrome
NAFLD, Non-alcoholic Fatty Liver Disease
Cardiovascular Diseases
Behavioral: Weightloss treatment program

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Danish Childhood Obesity Biobank

Resource links provided by NLM:

Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:

  • Weightloss, changes in blood parameters and in fatty liver developement. [ Time Frame: continuously ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: January 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
Lifestyle counseling: Experimental

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
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.

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 are measured. The children are 5-18 years old.

  Eligibility

Ages Eligible for Study:   5 Years to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Drop-outs
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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
Roskilde County Hospital
Holbaek Sygehus
University of Copenhagen
Steno Diabetes Center
Investigators
Study Chair: Jens-Christian Holm, Ph.d., MD The Children’s Obesity Clinic and The Danish Childhood Obesity Biobank
  More Information

No publications provided

Responsible Party: Jens-Christian Holm, The Children’s Obesity Clinic, Paediatric Department, University Hosp. Holbaek, Region Zealand, Denmark, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00928473    
History of Changes
Other Study ID Numbers: 250609
Study First Received: June 25, 2009
Last Updated: September 10, 2009
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:

Cardiovascular Diseases
Fatty Liver
Liver Diseases
Obesity
Weight Loss
Metabolic Syndrome X
Digestive System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 28, 2011

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