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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
  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: Intervention Model: Single Group Assignment
Masking: None (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 Jens Christian Holm, University of Copenhagen:

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

Estimated Enrollment: 5000
Study Start Date: January 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: June 25, 2009
First Posted: June 26, 2009
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