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

January 14, 2009
September 30, 2010
January 2009
August 2012   (final data collection date for primary outcome measure)
weightloss [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Weigthloss. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00823277 on ClinicalTrials.gov Archive Site
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
Bloodpresure. NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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:

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples of Whoole Blood.

Non-Probability Sample

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

  • Adipositas
  • NAFLD (Non-alcoholic Fatty Liver Disease)
  • Hypertension
  • Hyperlipidemia
  • Insulin Sensitivity
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.
1
Adipose Children 5-18 Years old associated at the Paediatric department, University Hospital Holbaek, Region Zealand, Denmark, University of Copenhagen
Intervention: Behavioral: Life-style. Weightloss.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
5 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00823277
130109, SJ-98
No
Dorthe Sadowa Frederiksen, Paediatric Department, University Hosp. Holbaek, Region Zealand, Denmark, University of Copenhagen
Roskilde County Hospital
  • Holbaek Sygehus
  • University of Copenhagen
  • Steno Diabetes Center
Principal Investigator: Dorthe S. Frederiksen, MD Paediatric department, University Hospital Holbaek, Region Zealand, University of Copenhagen, Denmark
Roskilde County Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP