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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48932

Enrollment

Registered

2018-08-21

Start date

2018-12-12

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver Disease hepatic steatosis

Interventions

None listed

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
- Change in ELF test compared to the measurement performed at the end of the lifestyle intervention in the previous study. - Change in percentage of liver steatosis measured by 1H-MRS compared to the measurement performed at the end of the lifestyle intervention in the previous study.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results