Weight Loss Clinical Trial
— NAFLDOfficial title:
NAFLD and Liver Fibrosis in Obese Adolescents Undergoing Weight Loss by Surgery or Life Style Intervention
Verified date | September 2020 |
Source | Tel-Aviv Sourasky Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease resulting from excessive
fat accumulation in the liver. Due to its close association with obesity, it has become the
most common liver disease in children in the United States. NAFLD can result in progressive
fibrosis and lead to end-stage liver disease. Best practices in management of pediatric NAFLD
are not clearly defined.
Our aim is to clarify the natural history of NAFLD in obese children after weight loss
surgery compare to lifestyle intervention. Our secondary aim is to investigate the added
value of elastography for the screening and diagnosis of NASH with fibrosis.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 1, 2019 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility |
IInclusion criteria: - Age 13-18 years. - No other chronic disease except the metabolic syndrome. - Not taking any medication Exclusion criteria: - Children that are known to suffer from genetic/metabolic disorders that can cause steatosis- Wilson disease, hypothyroidism, autoimmune hepatitis, Alpha 1 antitrypsin. - Children infected with HBV or HCV, HAV. - Children that use medications that can cause liver steatosis- amiodarone, MTX, Corticosteroids - Children with significant ethanol consumption ->10 gr per day for women and >20gr per day for men. - Pregnant women. - Obesity due to syndromes or monogenic disease General withdraw criteria: • If the participant withdraws his consent. |
Country | Name | City | State |
---|---|---|---|
Israel | Pediatric Gastroenterology | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in liver fibrosis | Liver fibrosis will be estimated by Shearwave elastography (Supersonic) and categorized into 4 levels, F0-F4, according to liver stiffness | 3 and 6 months | |
Secondary | change in liver steatosis | Liver steatosis will be calculated by a hepatorenal index (HRI) and divided into 3 levels of severity | 3 and 6 months | |
Secondary | weight reduction | BMI measurements | 3 and 6 months |
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