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

NCT00823277 | Completed

• 2 other identifiers: 130109SJ-98
• Study Type: observational
• Target: 517
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• weightloss

  1 Year

Secondary Outcomes (1)

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

  1 Year

Study Arms (1)

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

Other: Chronic care multidisciplinary intervention of childhood obesity

Interventions

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.

1

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Overweight and obese Children. 5-20 Years old. Paediatric Department, University Hospital Holbaek,Region Zealand, University of Copenhagen, Denmark

You may qualify if:

• Years old.
• Adipose. BMI \> 90 % percentile
• New patient in the Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek,Region Zealand, Denmark
• Informed Consent

You may not qualify if:

• Drop-outs

Sponsors & Collaborators

• Holbaek Sygehus: lead
• University of Copenhagen: collaborator
• Hagedorn Research Institute: collaborator
• The Novo Nordisk Foundation Center for Basic Metabolic Research: collaborator
• Herlev Hospital: collaborator

Study Sites (1)

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

Holbæk, 4300, Denmark

Location

Related Publications (3)

• 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.

  PMID: 21377308 RESULT

• 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.

  PMID: 22736224 RESULT

• 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.

  PMID: 25586046 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples of Whoole Blood.

MeSH Terms

Conditions

Pediatric Obesity; Non-alcoholic Fatty Liver Disease; Hypertension; Hyperlipidemias; Insulin Resistance

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Dorthe S. Bille, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D.

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: January 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

DK (1)