Inflammation Clinical Trial
Official title:
Lifestyle Intervention and Antioxidants in Children With Nonalcoholic Fatty Liver Disease: A Randomized, Controlled Trial
No proven treatment exists for nonalcoholic fatty liver disease (NAFLD) in children and adolescents. We aim to determine the efficacy of lifestyle intervention with or without antioxidant therapy in pediatric NAFLD.
InChildren or adolescents with well-characterized and liver biopsy confirmed NAFLD will be
enrolled. They will be randomized to treatment with alpha tocopherol 600 IU/d plus ascorbic
acid 500 mg/d (n=45) or an identical placebo (n=45) given orally. All patients will be
included in a lifestyle intervention program consisting of a diet tailored on the individual
requirements and physical exercise. The body mass index (BMI) and BMI Z-score will be
calculated . Obesity was defined for a percentile of BMI ≥ 95th percentile for age and
gender .
Patients will undergo a medical evaluation every three months during the 24-month study
period. Laboratory tests including liver enzymes and lipids will be repeated at 3-month
intervals during the 24-month study duration. Ultrasonography of the liver will be repeated
at the end of the study period.
Evaluation of Glucose Metabolism and Insulin Sensitivity A 2-hour oral glucose tolerance
test (OGTT) will be performed at baseline and repeated at 24 mo. of treatment with the
standard 1.75 g of glucose per kg, or maximum of 75 g. Glucose tolerance status will be
determined according to the classification of the American Diabetes Association in which
fasting plasma glucose (FPG) levels up to 99 mg/dl are considered normal; impaired fasting
glucose (IFG) is defined by a FPG of 100-125 mg/dl; impaired glucose tolerance (IGT) is
defined by a 2-hour plasma glucose of 140-199 mg/dl; diabetes mellitus is defined by a FPG
≥126 mg/dl, or a 2-hour plasma glucose ≥200 mg/dl .
The degrees of insulin resistance and sensitivity will be determined, respectively, by the
homeostatic model assessment (HOMA-IR) using the formula: IR = (insulin*glucose)/22.5; and
by the insulin sensitivity index (ISI) derived from OGTT using the formula: ISI =
(10,000/square root of [fasting glucose x fasting insulin] x [mean glucose x mean insulin
during OGTT]).
Liver biopsy Liver biopsy will be performed at baseline and repeated at 24 mo. of treatment.
Biopsies will be routinely processed and analyzed as described previously. Pre- and
post-treatment liver biopsies will be reviewed and scored by a single pathologist who will
be unaware of the assigned treatment, patients' clinical and laboratory data, and liver
biopsy sequence. The main histological features of NAFLD including steatosis (macro and
microvesicular), inflammation (portal and lobular), hepatocyte ballooning, and fibrosis will
be scored using the scoring system for NAFLD recently proposed by the NIH-sponsored NASH
Clinical Research Network.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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