Active clinical trials for "Non-alcoholic Fatty Liver Disease"

CONTROLLED TRIAL ON THE EFFECT OF TOMATO PRODUCTS IN OBESE CHILDREN WITH NON ALCOHOLIC FATTY LIVER DISEASE Aim of the study To evaluate the effect of the addition of a daily dose of lycopene enriched tomato sauce on the progress of NAFDL in obese children. Participants Children with obesity referred to the Hepatology unit of Dept.of Pediatric Clinic of the University Federico II of Naples. Diagnosis of NAFLD is made on the presence of fatty liver at ultrasound examination, with or without hypertransaminasemia. Patients are eligible on the basis of: Age 4-14 years BMI > 85°percentile Liver Steatosis evaluated as mild, moderate or severe by US (hyperechogenic liver tissue compared with the adjacent kidney cortex) Patients are excluded on the basis of: Liver disease Diabetes or manifest metabolic alterations Associated diseases Informed consent is obtained from the parents of the participating children. Sample size estimation To provide an 80% power to detect a 25% or greater relative shift of outcome variables, with a first degree error of .05 a sample of 50 cases is estimated in a cross over trial. Study design This is a randomized, crossover, one side open trial with blinded outcome evaluation. A statistician who is not otherwise involved in the trial generated the randomized assignment sequence. At the enrollment all participants received a low carotenoids diet for two weeks (wash out), then children are assigned to the first intervention for 8 weeks, and subsequently, in the crossover phase, they are switched to the second intervention for the next 8 weeks. No wash out is planned between the two treatments. Interventions Supplemented diet: 100 gr/day of Lycopene enriched tomato products (weekly average) Control diet: ordinary healthy diet, with no special encouragement to eat carotenes products All children are put on a 'mediterranean style' diet, with a controlled amount of calories: a dedicated dietitian for the whole study, irrespective of the treatment, checked their diet twice a week. At beginning (T0) and at the end of each treatment (T1 and T2) all patients underwent anthropomorphic measurements, including weight, height, waist, abdomen and hips circumferences. BMI and its standard deviation score are calculated. Regardless of group assignment, all participants are seen by a hepatologist at the end of each intervention and checked for liver steatosis, by US. Fasting blood samples are collected at beginning (T0) and at the end of each treatment (T1 and T2) to evaluate IR (assessed by HOMA), transaminases levels, lipids profile, oxidative state (assessed by antioxidant enzymes activity, serum levels of MDA and carbonylated proteins), inflammatory state (by cytokines serum levels, typing of lymphocytes subpopulations, metabolism of lymphocytes). Data collection are performed in a partially blind fashion: the statistician performing data analysis is blind to treatment. Outcomes: The primary outcome is reduction of the liver steatosis estimated by US Scan, according to the following parameters: parenchyma echogenicity (compared with that of the cortical of the right kidney), far gain attenuation, diaphragm blurring. steatosis. Secondary outcomes is reduction in Insulin resistance, Oxidative state, Inflammatory state. Statistical Analysis Data are inspected for normality and paired t-test (before/after) of each phase of the trial are performed when appropriate. The Median % change of each variable between the values at Time 8 and 16 weeks and values at enrollment are also looked. Ordinal logistic regression analysis, hierarchical, mixed model with adjustment variables are adopted to estimate the size of the effect. The study is approved by the Ethical Committee of University Federico II of Naples.

The main objective of this randomised pilot study is to explore the relative efficacy of dietary MLCT oil versus LCT oil (corn oil) in augmenting therapy of overweight and obese NAFLD patients with at least a 1-stage reversal between F1 and F4.

Evaluate the effect of supplementation of probiotics on liver changes (histological and enzymatic), lipid profile and gut microbiota of patients with nonalcoholic steatohepatitis (NASH).

Primary objective To investigate the effect of a 24-week, twice daily dosing regimen of ARI-3037MO compared to placebo on plasma triglyceride (TG) levels, liver enzymes and hepatic fat content in patients with dysglycemia and hepatic steatosis due to nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). Secondary Objective To investigate the safety and tolerability of a 24-week, twice daily dosing regimen of ARI-3037MO compared to placebo in patients with dysglycemia and evidence of NAFLD or NASH.

NAFLD (Non-alcoholic fatty liver disease) has become the most common cause of liver disease in Western countries (hepatic manifestation of insulin resistance); NAFLD represents a cardiovascular risk factor; Lifestyle modification(weight loss)is the effective medical treatment recommended for NASH (Non-alcoholic Steatohepatitis); Ezetimibe could represent a novel safe treatment for NAFLD (Patel 2006. Here the investigators propose a Randomized Controlled Pilot Trial to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.

Non-alcoholic fatty liver disease (NAFLD) is defined by presence of hepatic steatosis (fat accumulation in liver cells), either by imaging or by biopsy and absence of causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, or hereditary disorders. In the majority of patients, NAFLD is associated with risk factors for cardiovascular disease such as obesity, diabetes mellitus, and high cholesterol, and may lead to irreversible liver damage. Non-alcoholic steatohepatitis (NASH) is a more severe form of NAFLD and is present in up to 30% of obese adults. NASH is defined by hepatic steatosis and inflammation with hepatocyte injury with or without fibrosis (hardening of the liver). The prevalence, morbidity and mortality of NAFLD is increasing, particularly in the Asia-Pacific region where there will be an estimated 300 million obese people by 2030. Weight loss is the first-line treatment for NAFLD in obese individuals, but the utility of lifestyle modification with diet and exercise is limited by difficulties in sustaining compliance and by eventual weight regain. Bariatric (weight loss) surgery produces the greatest amount of weight loss but is limited by cost, patient acceptance, and complications. The efficacy of drugs for NASH, such as vitamin E and medication to lower cholesterol and glucose, remains unclear. Liraglutide, a glucagon-like peptide (GLP-1) analogue, is an injectable medication which has been shown to induce weight loss and lower glucose in obese adults. There is little information on the effects of GLP-1 analogues on NASH, particularly in comparison to other modalities of weight loss such as surgery. This study aims to compare the efficacy and safety of lifestyle modification, liraglutide and surgery, for weight loss in conjunction with reducing severity of NASH, and for insulin resistance, high cholesterol and other cardiovascular risk factors.

The aim of the present study was to compare the effects of simvastatin and L-carnitine coadministration versus simvastatin, L-Carnitine monotherapy on liver transaminases and liver elasticity in NASH patients.

Non-alcoholic fatty liver disease (NAFLD) represents a spectrum of disorders characterized by predominantly macrovesicular hepatic steatosis occurring in individuals in the absence of significant alcohol consumption. In this context it is possible to distinguish a condition of simple fatty liver, where the only histologic finding is the presence of steatosis, from a state of non-alcoholic steatohepatitis (NASH), characterized by hepatocellular injury/inflammation with or without fibrosis. The prevalence of NAFLD is around 20-30% in the general population. With a rapid increase in the risk factors for metabolic syndrome, NAFLD has become the most common cause of liver disease in Western countries. The clinical relevance of NAFLD arises from the fact that a considerable proportion of subjects (20-30%) develop NASH, and this condition can progress to cirrhosis in up to 15% of patients. In addition NAFLD, and particularly NASH, represents a cardiovascular risk factor, independent of other well-known conditions contributing to heart and vascular diseases. Lifestyle modification is the effective medical treatment recommended for NASH, while there is currently no pharmacologic therapy of proven benefit in these patients. Several pilot studies, using insulin sensitizers (thiazolidinediones or metformin), and antioxidants, like vitamin E, have provided inconclusive evidence that these drugs may improve clinical and histological features of NASH. In the complex and not completely understood pathogenic puzzle of NAFLD and NASH, also vitamin D might have an important role. Vitamin D deficiency is associated with many common pathological conditions frequently observed in NAFLD, like cardiovascular disease, and insulin resistance. A recent paper by Targher and colleagues showed low vitamin D serum levels in NAFLD patients, identifying an inverse relation between vitamin D levels and the severity of liver disease. In keeping with the above data, recent experimental evidence also suggested the potential ability of vitamin D, through interaction with its nuclear receptor (vitamin D receptor - VDR), to interfere with inflammatory response, T cell function and fibrogenesis. Therefore considering the link between vitamin D serum levels, severity of NAFLD, and risk factors for NAFLD, we speculate that vitamin D might represent a new therapeutic target in the management of NASH patients.

The first line approach to NAFLD is currently based on diet and lifestyle modification. Aim of our Unit is to compare the efficacy of two different doses of metformin (1 g/day and 2 g/day) with atorvastatin (20 mg/day) on amelioration of inflammatory and cardiometabolic parameters, ultrasound signs and clinical scores associated with liver fibrosis in early-stage NAFLD non-diabetic patients.

Nonalcoholic hepatic steatosis (NASH) is defined as the amount greater than 5% of the total liver volume fat. Commonly known as NASH, it includes 4 stages histological ranging from the mere presence of fat to the existence of fibrosis and degeneration of hepatocytes, and finally a progression to cirrhosis, sometimes accompanied by complications of hepatocellular carcinoma. It is a common condition associated with a combination of disorders, namely obesity, insulin resistance and type 2 diabetes. The link with the metabolic syndrome (MetS) was mainly studied in the adult population and very little in the paediatric population, while 15 and 25% of obese children are affectés. The severity of histological disease appears to be associated with the degree of obesity in children and particularly in the MetS. in addition, epidemiological data indicate that the incidence of this disease is increasing in children and positioning as the first NASH liver disease in North America. the revelation of the factors associated with the occurrence of NASH is a first necessary step to understanding this disorder worrying for the future of children and adolescents. In addition, clarification of the mechanisms responsible for its development is essential if the investigators want to consider targeted and effective treatments to slow the rat race of NASH, which stands out as the supreme chronic liver accompanying the obesity and MetS. Finally, in view of growth and puberty of children, it would be extremely beneficial to find nutritional avenues that would avoid the side effects of chemical agents.