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

Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823277
• Other study ID #: 130109
• Secondary ID: SJ-98
• Status: Completed
• Start date: January 2009
• Est. completion date: August 2012

Study information

• Verified date: July 2023
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Fatty Liver
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Insulin Resistance
• Insulin Sensitivity
• Liver Diseases
• Metabolic Syndrome
• NAFLD (Non-alcoholic Fatty Liver Disease)
• Non-alcoholic Fatty Liver Disease
• Overweight
• Pediatric Obesity
• Weight Loss

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	The Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek, Region Zealand, University of Copenhagen	Holbaek

Sponsors (5)

Lead Sponsor	Collaborator
Holbaek Sygehus	Hagedorn Research Institute, Herlev Hospital, The Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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- — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weightloss		1 Year
Secondary	NAFLD (non-alcoholic Fatty Liver Disease).Gene-polymorphs	Nafld measured by Magnet resonance spectroscopy. Sequencing of MC4R	1 Year