Nonalcoholic Fatty Liver Disease (NAFLD)NCT01544751
Nonalcoholic Fatty Liver Disease (NAFLD) Pharmacological Treatment: Metformin Versus Atorvastatin
A study testing Low dose metformin, Metformin and Atorvastatin in people with Nonalcoholic Fatty Liver Disease (NAFLD), run by Prof Antonino Belfiore at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- Low dose metformin, Metformin and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Endocrinology Unit
Catanzaro, Catanzaro, 88100
Angela Mazza, Post doc, +03909613647110, angela_mazza@libero.it
Barbara Fruci, Doctor, +03909613647110, barbara.fruci@yahoo.it
About this study
Official title: Metformin Versus Atorvastatin in Nonalcoholic Hepatic Steatosis: a Randomized Study
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.
Read the detailed 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.
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD)
- Being tested
- Low dose metformin, Metformin, Atorvastatin
- Keywords
- NAFLD, metformin, atorvastatin, metabolic syndrome
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose metforminDrug
500 mg twice a day
MetforminDrug
1000 mg twice a day
AtorvastatinDrug
20 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Low dose Metformin | Active comparator | 500 mg twice a day for one year Receives: Drug: Low dose metformin |
| Metformin | Active comparator | 1000 mg twice a day for one year Receives: Drug: Metformin |
| Atorvastatin | Active comparator | 20 mg day Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with improvement of liver hyperechogenicity
We will investigate efficacy of metformin and atorvastatin in amelioration of liver hyperechogenicity and fibrosis scores.
Measured: one year
Secondary outcomes (1)
Number of Participants with amelioration of metabolic syndrome and HOMA-Index
We will investigate efficacy of metformin and atorvastatin in amelioration of metabolic parameters (change in the number of patients with metabolic syndrome from baseline and after treatment and amelioration of HOMA-Index from Baseline at one years).
Measured: one years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Antonino Belfiore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Antonino Belfiore, University Magna Graecia
- Investigators
- Antonino Belfiore, Director, Study director, Endocrinology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544751
- Sponsor's protocol ID
- 2010.42
- Status last verified
- May 2014
- First submitted
- 16 Feb 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Versus Atorvastatin in Nonalcoholic Hepatic Steatosis: a Randomized Study
- ClinicalTrials.gov ID
- NCT01544751
- Acronym / sponsor ID
- 2010.42
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD)
- Keywords
- NAFLD, metformin, atorvastatin, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Prof Antonino BelfioreUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose Metformin | Active comparator | Drug: Low dose metformin500 mg twice a day for one year |
| Metformin | Active comparator | Drug: Metformin1000 mg twice a day for one year |
| Atorvastatin | Active comparator | Drug: Atorvastatin20 mg day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age <=55
- BMI <=40
- Total cholesterol <=280 mg/dl
- LDL <=180 mg/dl
- Triglycerides <=200 mg/dl
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose metformin500 mg twice a day | Drug | Low dose Metformin |
| Metformin1000 mg twice a day | Drug | Metformin |
| Atorvastatin20 mg/day | Drug | Atorvastatin |
Primary outcome
Number of Participants with improvement of liver hyperechogenicity
Time frame: one year
We will investigate efficacy of metformin and atorvastatin in amelioration of liver hyperechogenicity and fibrosis scores.
1 secondary outcome
Number of Participants with amelioration of metabolic syndrome and HOMA-Index
Time frame: one years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonino Belfiore, Director study director
Endocrinology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose metformin, Metformin and Atorvastatin in people with Nonalcoholic Fatty Liver Disease (NAFLD), run by Prof Antonino Belfiore at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanbattista De sarro, Professor (+03909613647110, desarro@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with improvement of liver hyperechogenicity (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.