Nonalcoholic Fatty Liver Disease (NAFLD) Pharmacological Treatment: Metformin Versus Atorvastatin
Metformin Versus Atorvastatin in Nonalcoholic Hepatic Steatosis: a Randomized Study
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
March 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 28, 2014
May 1, 2014
3.8 years
February 16, 2012
May 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with improvement of liver hyperechogenicity
We will investigate efficacy of metformin and atorvastatin in amelioration of liver hyperechogenicity and fibrosis scores.
one year
Secondary Outcomes (1)
Number of Participants with amelioration of metabolic syndrome and HOMA-Index
one years
Study Arms (3)
Low dose Metformin
ACTIVE COMPARATOR500 mg twice a day for one year
Metformin
ACTIVE COMPARATOR1000 mg twice a day for one year
Atorvastatin
ACTIVE COMPARATOR20 mg day
Interventions
Eligibility Criteria
You may qualify if:
- Age \<=55
- BMI \<=40
- Total cholesterol \<=280 mg/dl
- LDL \<=180 mg/dl
- Triglycerides \<=200 mg/dl
- AST and ALT in the normal range
- Signs of simple liver steatosis at ultrasonorography.
You may not qualify if:
- Type 2 diabetes
- Heart disease
- Renal failure
- Smoking habit
- Alcohol intake of more than 20 g per day in the case of women and more than 30 g per day in the case of men
- Hepatic virus infection
- Autoimmune, metabolic or genetic liver diseases
- Use of drugs known to induce liver steatosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Endocrinology Unit
Catanzaro, Catanzaro, 88100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Antonino Belfiore, Director
Endocrinology Unit
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
February 16, 2012
First Posted
March 6, 2012
Study Start
September 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 28, 2014
Record last verified: 2014-05