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Completed

NCT Number: NCT00823277

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

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.

Completed

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Key information

Conditions

Childhood Obesity Body Weight Cardiovascular Diseases Digestive System Diseases Dyslipidemias Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemia Hyperlipidemias Hypertension Insulin Resistance Insulin Sensitivity Lipid Metabolism Disorders Liver Diseases Metabolic Diseases NAFLD (Non-Alcoholic Fatty Liver Disease) Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Vascular Diseases

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Holbæk, 4300, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chronic care multidisciplinary intervention of childhood obesity

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.

Primary outcomes

  1. weightloss

    Time frame: 1 Year

Secondary outcomes

  1. NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs

    Time frame: 1 Year

    Nafld measured by Magnet resonance spectroscopy. Sequencing of MC4R

Sponsors and collaborators

Lead sponsor

Holbaek Sygehus

Other

Collaborators

  • Hagedorn Research Institute
  • Herlev Hospital
  • The Novo Nordisk Foundation Center for Basic Metabolic Research
  • University of Copenhagen

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 15, 2009
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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