Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Non alcoholic fatty liver disease (NAFLD) is a common liver disease that encompasses both simple steatosis and non alcoholic steatohepatitis (NASH.

There is currently no therapy that is of proven benefit for these liver disorders both of which are closely associated with insulin resistance and features of the metabolic syndrome such as obesity, hyperlipidaemia and type 2 diabetes mellitus. The first line approach to NAFLD is currently based on diet and lifestyle modification. However, dietary treatment is limited by the lack of compliance and the frequent regain of weight at follow-up.

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.

The investigators will enrol obese or overweight non-diabetic patients with ultrasonographic diagnosis of hepatic steatosis at early stage (NAFLD). The investigators will exclude from the study patients with clinical-biochemical and ultrasound markers of disease severity (age, BMI, lipid profile, AST, ALT, Angulo, BAAT and HAIR clinical fibrosis scores, signs of portal hypertension and posterior attenuation of the deep liver parenchyma at US). Patients who meet all eligibility criteria will be randomly assigned to one of three groups for 12 months of study treatment. The first group (n=50) will receive metformin (1g/day) plus dietary treatment; the second group (n=50) will be given metformin (2 g/day) and the third group (n=50) will be treated with atorvastatin (20 mg/day). All participants will be followed-up at 3, 6, 9, 12 months intervals after randomization. We will compare the effects of two doses of metformin with atorvastatin on the amelioration of both inflammatory (PCR, TNF-a , IL-6) and metabolic parameters (lipid profile, BMI, waist circumference, fasting glucose, 2-h glucose tolerance test, insulin, transaminases, adiponectin,leptin, HOMA-IR index and VAI index). Furthermore, we will assess the improvement under drug treatment of liver steatosis on the basis of US signs (liver echogenicity and stiffness) and of fibrosis scoring systems (Angulo, BAAT and HAIR scores).

In conclusion, considering the increasing prevalence of NAFLD and its strong association with cardiovascular diseases and cancer, the investigators expect to identify a safe pharmacological regimen that, in addition to dietary treatment, may ameliorate or even reverse this liver disease and the underlying risk factors. This study could have an important social impact in terms of both preventive and therapeutic interventions. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01544751
Study type Interventional
Source University Magna Graecia
Contact Giovanbattista De sarro, Professor
Phone +03909613647110
Email desarro@unicz.it
Status Recruiting
Phase N/A
Start date September 2011
Completion date June 2015

See also
  Status Clinical Trial Phase
Terminated NCT02244944 - Ezetimibe-Ursodiol Combination Therapy on Biomarkers of Liver Function and Sterol Balance in Subjects With NAFLD Phase 2
Recruiting NCT03572465 - Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
Enrolling by invitation NCT04059029 - Nonalcoholic Fatty Liver Disease in Morbidly Obese Patients
Terminated NCT01930123 - Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance Biomarkers in Nonalcoholic Fatty Liver Disease Phase 2
Recruiting NCT01705522 - Multimodal Approach in IBD Patients
Recruiting NCT03525769 - Screening With FibroTouch for Advanced Liver Fibrosis in NAFLD Patients With Underlying Type 2 Diabetes
Recruiting NCT06024408 - A Trial to Learn if Receiving ALN-PNP siRNA is Safe and Well Tolerated, and How it Works in Adult Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a Genetic Risk Factor Phase 1
Completed NCT01265498 - The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT) Phase 2
Completed NCT01529268 - Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children Phase 2/Phase 3
Completed NCT02217345 - Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease Phase 2
Completed NCT03486899 - A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis Phase 2
Completed NCT02781584 - Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH) Phase 2
Completed NCT03486912 - A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis Phase 2
Completed NCT02196831 - Tesamorelin Effects on Liver Fat and Histology in HIV N/A
Withdrawn NCT03451279 - A Nonabsorbable Ileal Apical Sodium-Dependent Bile Acid Transporter Inhibitor for Nonalcoholic Steatohepatitis Phase 2
Completed NCT02044523 - Noninvasive Staging of Liver Fibrosis: MR vs Ultrasound
Completed NCT03836443 - Postprandial Lipotoxicity and Nonalcoholic Fatty Liver Disease N/A
Completed NCT03042767 - Anti-LPS Antibody Treatment for Pediatric NAFLD Phase 2
Recruiting NCT02213224 - Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease Phase 4
Completed NCT03459079 - Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease Phase 2