- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00823277
Metabolic Syndrome and Gen-polymorphs Influence on Weightloss Among Children in Treatment for Overweight
Indicators for the Metabolic Syndrome as Well as the Influence of Different Gen-polymorphs on Weightloss and the Maintenance of Lower Weight Among Children in Treatment for Overweight
Definition:
the overall objective is to examine childhood obesity with focus on NAFLD and its treatment. Further, we aimed to investigate the impact of genetic variation on obesity.
The specific aims are to;
- describe the degree of NAFLD among overweight and obese, Danish children. (hypothesis; the degree for pediatric NAFLD among Danish Children was equal that found in other Caucasian paediatric study populations).
- investigate the effect of a multidisciplinary intervention treatment of 1 year on liver fat content.
(hypothesis; the intervention could reduce the liver fat percentage and a reduction in BMI SDS would associate with a reduction in liver fat content) - Analyze changes in liver fat content in relation to changes in levels of fasting blood variables to see if any of them could be used as a clinical tool for monitoring hepatic steatosis in the clinic.
(hypothesis; serum aminotransferases (separately and their ratio, respectively), serum insulin, and HOMA-IR could predict improvement in liver fat content
- Investigate the association between genetic variants and obesity.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Holbaek, Denmark, 4300
- The Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek, Region Zealand, University of Copenhagen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 5- 20 Years old.
- Adipose. BMI > 90 % percentile
- New patient in the Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek,Region Zealand, Denmark
- Informed Consent
Exclusion Criteria:
- Drop-outs
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Overweight and obese Children (BMI SDS > 90th percentile according to Danish BMI sheets) 5-20 Years of age.
Recruited from the Paediatric department, University Hospital Holbaek, Region Zealand, Denmark, University of Copenhagen
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Overweight and obese Children, 5-20 Years old, followed by Paediatricians and other Health Personals (multidisciplinary team).
Included at their first visit in the clinic (baseline)and follow-up after ~ 1 Year.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weightloss
Time Frame: 1 Year
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1 Year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs
Time Frame: 1 Year
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Nafld measured by Magnet resonance spectroscopy.
Sequencing of MC4R
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1 Year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dorthe S. Bille, MD, Paediatric department, University Hospital Holbaek, Region Zealand, University of Copenhagen, Denmark
Publications and helpful links
General Publications
- Chabanova E, Bille DS, Thisted E, Holm JC, Thomsen HS. MR spectroscopy of liver in overweight children and adolescents: investigation of (1)H T(2) relaxation times at 3T. Eur J Radiol. 2012 May;81(5):811-4. doi: 10.1016/j.ejrad.2011.02.017. Epub 2011 Mar 4.
- Chabanova E, Bille DS, Thisted E, Holm JC, Thomsen HS. (1)H MRS assessment of hepatic steatosis in overweight children and adolescents: comparison between 3T and open 1T MR-systems. Abdom Imaging. 2013 Apr;38(2):315-9. doi: 10.1007/s00261-012-9930-2.
- Bille DS, Chabanova E, Gamborg M, Fonvig CE, Nielsen TR, Thisted E, Thomsen HS, Holm JC. Liver fat content investigated by magnetic resonance spectroscopy in obese children and youths included in multidisciplinary treatment. Clin Obes. 2012 Feb;2(1-2):41-9. doi: 10.1111/j.1758-8111.2012.00038.x. Epub 2012 Apr 24.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Overnutrition
- Nutrition Disorders
- Body Weight
- Hyperinsulinism
- Body Weight Changes
- Lipid Metabolism Disorders
- Dyslipidemias
- Obesity
- Liver Diseases
- Fatty Liver
- Metabolic Syndrome
- Pediatric Obesity
- Weight Loss
- Insulin Resistance
- Overweight
- Non-alcoholic Fatty Liver Disease
- Hyperlipidemias
Other Study ID Numbers
- 130109
- SJ-98
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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