Metabolic Syndrome and Gen-polymorphs Influence on Weightloss Among Children in Treatment for Overweight

This study has been completed.
Sponsor:
Collaborators:
Holbaek Sygehus
University of Copenhagen
Hagedorn Research Institute
The NNF, Center for Basic Metabolic Research, Section of Metabolic Genetics
The Diagnostic Radiology Department, Herlev Hospital
Information provided by (Responsible Party):
Dixi Louise Strand, Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT00823277
First received: January 14, 2009
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Childhood Obesity
NAFLD (Non-alcoholic Fatty Liver Disease)
Hypertension
Hyperlipidemia
Insulin Sensitivity
Other: Chronic care multidisciplinary intervention of childhood obesity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:
  • weightloss [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Nafld measured by Magnet resonance spectroscopy. Sequencing of MC4R


Biospecimen Retention:   Samples With DNA

Blood samples of Whoole Blood.


Enrollment: 517
Study Start Date: January 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other: Chronic care multidisciplinary intervention of childhood obesity
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.

  Eligibility

Ages Eligible for Study:   5 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Overweight and obese Children. 5-20 Years old. Paediatric Department, University Hospital Holbaek,Region Zealand, University of Copenhagen, Denmark

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823277

Locations
Denmark
The Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek, Region Zealand, University of Copenhagen
Holbaek, Denmark, 4300
Sponsors and Collaborators
Roskilde County Hospital
Holbaek Sygehus
University of Copenhagen
Hagedorn Research Institute
The NNF, Center for Basic Metabolic Research, Section of Metabolic Genetics
The Diagnostic Radiology Department, Herlev Hospital
Investigators
Principal Investigator: Dorthe S. Bille, MD Paediatric department, University Hospital Holbaek, Region Zealand, University of Copenhagen, Denmark
  More Information

Publications:
Responsible Party: Dixi Louise Strand, MD, Roskilde County Hospital
ClinicalTrials.gov Identifier: NCT00823277     History of Changes
Other Study ID Numbers: 130109, SJ-98
Study First Received: January 14, 2009
Last Updated: April 30, 2014
Health Authority: Denmark: Ethics Committee
Collaberators in Denmark: The Novo Nordisk Foundation, Center for Basic Metabolic Research, Section of Genetics, Denamrk
Denmark: Diagnostic Radiology Department, Herlev University Hospital, Denmark

Additional relevant MeSH terms:
Fatty Liver
Hyperlipidemias
Hypertension
Liver Diseases
Obesity
Weight Loss
Overweight
Metabolic Syndrome X
Insulin Resistance
Pediatric Obesity
Digestive System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on August 28, 2014