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

Tracking Information

First Received Date ^ICMJE

January 14, 2009

Last Updated Date

September 30, 2010

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

weightloss [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Weigthloss. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00823277 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Bloodpresure. NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Blood samples of Whoole Blood.

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Adipositas
NAFLD (Non-alcoholic Fatty Liver Disease)
Hypertension
Hyperlipidemia
Insulin Sensitivity

Intervention ^ICMJE

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.

Study Group/Cohort (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

August 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00823277

Other Study ID Numbers ^ICMJE

130109, SJ-98

Has Data Monitoring Committee

Responsible Party

Dorthe Sadowa Frederiksen, Paediatric Department, University Hosp. Holbaek, Region Zealand, Denmark, University of Copenhagen

Study Sponsor ^ICMJE

Roskilde County Hospital

Collaborators ^ICMJE

Holbaek Sygehus
University of Copenhagen
Steno Diabetes Center

Investigators ^ICMJE

Principal Investigator:

Dorthe S. Frederiksen, MD

Paediatric department, University Hospital Holbaek, Region Zealand, University of Copenhagen, Denmark

Information Provided By

Roskilde County Hospital

Verification Date

September 2010

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

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