Non alcoholic fatty liver disease and Non alcoholic steato hepatitis in Obese children.
Conditions
Interventions
The study will be carried out at the Obesity clinic conducted by Ward 01 (Professorial Pediatric Unit of University of Colombo) Lady Ridgeway Hospital for Children.
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Sponsors
Department of Paediatrics, Faculty of Medicine, University of Colombo
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age limit: 5yrs - 15yrs 2. Sex: males and females 3. Body Mass Index +2 standard deviations (SD) above the median BMI for age reference (using WHO, 2007 standards) 4. Diagnosis of NAFLD/ NASH with AST/ ALT ratio less than 1 and ultra sound scan evidence of NAFLD/ NASH.
Exclusion criteria
Exclusion criteria: 1. Children with acute infection, 2. Long term medications (> 3 months continuously) 3. Long standing illness on long term medication 4. Children with inherited conditions. 5. Administration of antibiotics in the 2 month period before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in Alanine transaminase (ALT), Aspartate aminotransferase (AST) 2. Reversal of AST:ALT ratio 3. Transient elastographic (fibroscan) assessment of stiffness of the liver and quantification of steatosis 4. Ultrasound grade of NAFLD/ NASH. [At baseline (just before commencement of therapy) and 6 months after completion of the course of therapy.] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in GT (gamma glutamyl transferase), 2. Improvement of the lipid profile 3. Improvement in glucose homeostasis, metabolic syndrome, fat mass of body and anterior abdominal wall subcutaneous fat 4. Improvement of anthropometric parameters. [Outcomes 1-3 will be measured at baseline and at 6 months following commencement of the intervention Outcome 4 will be measured at baseline and then monthly for a total of 6 months ] | — |
Countries
Sri Lanka
Contacts
Public ContactV. Pujitha Wickramasinghe
Professor in Paediatrics
Outcome results
None listed