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
Recruitment status was Recruiting
Sponsor:
Roskilde County Hospital
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
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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 |
|---|---|
|
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 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 May 16, 2013