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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Roskilde County Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Holbaek Sygehus
University of Copenhagen
Steno Diabetes Center
Information provided by:
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT00823277
First received: January 14, 2009
Last updated: September 30, 2010
Last verified: September 2010
History of Changes
  Purpose

Definition:

This Study has the Purpose to look at Children in treatment for Overweight. The investigators will investigate how The Metabolic Syndrome and adipositas related gene-polymorphs are related to overweight, weight loss and weight gain among Children in treatment of overweight.

The Metabolic Syndrome is defined as Abdominal Obesity and /or high BMI (Body mass index)and at least one of the following circumstances; Hypertension, Dyslipidaemia and insulin-resistance .

Study Hypothesis:

This Study will see, how Indicators as Abdominal Obesity, Hypertension, Dyslipidaemia and Insulin-resistance influence on weight loss and the Ability to remain this lower weight among adipose Children.

This Study will see, how NAFLD (non-alcoholic fatty liver disease) influences on weight loss and the Ability too remain this lower weight among adipose Children.

This Study will see, how NAFLD (non-alcoholic fatty liver disease)and Insulin Resistance will get normalized as adiposed Children are becoming a weight loss.

This Study will see, how serological markers as the Interleukines (IL) 2,6,8,10,12,17, the Cytokines; MBL, Interferon gamma, B27, TNF alfa and BNP are associated with Adipositas.

This Study will see, how gene-polymorphs influence on weight loss among adipose Children.


Condition Intervention
Adipositas
NAFLD (Non-alcoholic Fatty Liver Disease)
Hypertension
Hyperlipidemia
Insulin Sensitivity
 Behavioral: Life-style. Weightloss.

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:

U.S. FDA Resources

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.


Estimated Enrollment: 600
Study Start Date: January 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Adipose Children 5-18 Years old associated at the Paediatric department, University Hospital Holbaek, Region Zealand, Denmark, University of Copenhagen
 Behavioral: Life-style. Weightloss.
Adipose Children, 5-18 Years old, followed by Paediatricians and other Health Personals. Base-line when included and follow-up after 1 Year.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adipose Children. 5-18 Years old. Paediatric Department, University Hospital Holbaek,Region Zealand, University of Copenhagen, Denmark

Criteria

Inclusion Criteria:

  • 5- 18 Years old.
  • Adipose. BMI > 97 % percentile
  • New patient in the Unit of Adipositas, Paediatric Department, University Hospital Holbaek,Region Zealand, Denmark
  • Informed Consent

Exclusion Criteria:

  • Drop-outs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823277

Locations
Denmark
Paediatric Department, University Hospital Holbaek, Region Zealand, University of Copenhagen
Holbaek, Denmark, 4300
Sponsors and Collaborators
Roskilde County Hospital
Holbaek Sygehus
University of Copenhagen
Steno Diabetes Center
Investigators
Principal Investigator: Dorthe S. Frederiksen, MD Paediatric department, University Hospital Holbaek, Region Zealand, University of Copenhagen, Denmark
  More Information

No publications provided

Responsible Party: Dorthe Sadowa Frederiksen, Paediatric Department, University Hosp. Holbaek, Region Zealand, Denmark, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00823277     History of Changes
Other Study ID Numbers: 130109, SJ-98
Study First Received: January 14, 2009
Last Updated: September 30, 2010
Health Authority: Denmark: Ethics Committee
Collaberators in Denmark: Hagedorn Research Institutte and Diagnostic Radiology Department, Herlev University Hospital

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

ClinicalTrials.gov processed this record on June 18, 2013