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

NCT ID: NCT00823277

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Chronic care multidisciplinary intervention of childhood obesity

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Hagedorn Research Institute

OTHER

Sponsor Role collaborator

The Novo Nordisk Foundation Center for Basic Metabolic Research

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role collaborator

Holbaek Sygehus

OTHER

Sponsor Role lead

Responsible Party

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Jens-Christian Holm

MD, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dorthe S. Bille, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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The Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek, Region Zealand, University of Copenhagen

Holbæk, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 21377308 (View on PubMed)

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.

Reference Type RESULT
PMID: 22736224 (View on PubMed)

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.

Reference Type RESULT
PMID: 25586046 (View on PubMed)

Other Identifiers

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SJ-98

Identifier Type: -

Identifier Source: secondary_id

130109

Identifier Type: -

Identifier Source: org_study_id

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