The natural history of Non-alcoholic Fatty Liver Disease in obese children: a long-term follow-up study.

Completed

Conditions: Fatty Liver Disease
hepatic steatosis
10019654

Registration Number: NL-OMON48932

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 79

Inclusion Criteria

All patients who participated in the original study will be contacted.

Exclusion Criteria

- Other liver disease (viral/autoimmune hepatitis, M. Wilson, haemochromatosis,
alfa1-antitrypsine deficiency)
- Metabolic disease (beta-oxidation defects, urea cyclus defects)
- Use of steatogenic medication
- Alcohol consumption > 140 g/week
- Jejuno-ileal surgery
- History of parenteral feeding

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Change in ELF test compared to the measurement performed at the end of the<br /><br>lifestyle intervention in the previous study.<br /><br>- Change in percentage of liver steatosis measured by 1H-MRS compared to the<br /><br>measurement performed at the end of the lifestyle intervention in the previous<br /><br>study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Difference in proportion of subjects with steatosis (defined as fat<br /><br>percentage > 1.8%) at the end of the lifestyle intervention and at 6-10 years<br /><br>follow-up.<br /><br>* Change in co-variables including insulin resistance, glucose, serum ALT<br /><br>level, HDL- and LDL-cholesterol.<br /><br>* Association between change of steatosis and (change in) several parameters:<br /><br>sex, BMI, age corrected SD score, waist circumference, levels of serum alanine<br /><br>aminotransferase and insulin sensitivity index (HOMA).<br /><br>* Association between microalbuminuria and NAFLD (steatosis and fibrosis)</p><br>