Liver DiseasesNCT00247117
Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
A study testing Metformin in people with Liver Diseases, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Metformin
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2004to Aug 2005
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ALT > 2 times normal range.
- Liver histology revealing non-alcoholic steatohepatitis [NASH] (type 2-4), without cirrhosis.
- Clinical characteristics of the metabolic syndrome as defined by the National Cholesterol Education Program (NCEP), but no overt diabetes.
- Negative work-up for other causes of liver diseases including alcohol intake < 40 g/week.
Who cannot join
- Diabetes mellitus.
- Alcohol intake > 40 g per week.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Institute of Endocrinology, Kaplan Medical Center
Rehovot, 76100
About this study
Official title: Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease
The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome.
Read the detailed description
Study population:
30 patients will be included who meet all the following criteria: ALT > 2 times normal range; liver histology revealing NASH (type 2-4), without cirrhosis; clinical characteristics of the metabolic syndrome as defined by the NCEP, but no overt diabetes; negative work-up for other causes of liver diseases including alcohol intake < 40 g/week.
All patients will undergo liver biopsy and only patients with type 2-4 (steatosis + inflammation, or steatosis plus ballooning degeneration, or steatosis plus fibrosis and/or Mallory bodies) but without cirrhosis will be included.
Patients who received lipid lowering medications or anti hypertensive drugs prior to study will continue the treatment. Patients who will develop overt type 2 DM with HbAic > 7% during study will be withdrawn.
Intervention:
All patients will have dietary intervention by a dietician and will be encouraged to increase physical activity. Patients will be receiving metformin 850 mg tid for 12 months.
Outcome:
- Improvement of liver enzymes (ALT, AST, GGT)
- Improvement of metabolic profile: lipid profile, fasting and post-load glucose and insulin levels, HOMA.
- Liver histology (repeated liver biopsy after 1 year).
- Soluble TNF receptors- TNF-receptor P55 and P75.
- Conditions
- Liver Diseases
- Being tested
- Metformin
- Keywords
- non-alcoholic fatty liver disease, insulin resistance, metformin
- Medical subject headings
- Liver Diseases, Non-alcoholic Fatty Liver Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
histological and biochemical changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startJan 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Stephen D Malnick, MD, Study director, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247117
- Sponsor's protocol ID
- 037-2003
- Status last verified
- Oct 2003
- First submitted
- 31 Oct 2005
- Last updated
- 9 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT00247117
- Acronym / sponsor ID
- 037-2003
- Conditions
- Liver Diseases
- Keywords
- non-alcoholic fatty liver disease, insulin resistance, metformin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Aug 2005
- First posted
- 1 Nov 2005 (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 purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome.
Detailed description
Study population:
30 patients will be included who meet all the following criteria: ALT > 2 times normal range; liver histology revealing NASH (type 2-4), without cirrhosis; clinical characteristics of the metabolic syndrome as defined by the NCEP, but no overt diabetes; negative work-up for other causes of liver diseases including alcohol intake < 40 g/week.
All patients will undergo liver biopsy and only patients with type 2-4 (steatosis + inflammation, or steatosis plus ballooning degeneration, or steatosis plus fibrosis and/or Mallory bodies) but without cirrhosis will be included.
Patients who received lipid lowering medications or anti hypertensive drugs prior to study will continue the treatment. Patients who will develop overt type 2 DM with HbAic > 7% during study will be withdrawn.
Intervention:
All patients will have dietary intervention by a dietician and will be encouraged to increase physical activity. Patients will be receiving metformin 850 mg tid for 12 months.
Outcome:
- Improvement of liver enzymes (ALT, AST, GGT)
- Improvement of metabolic profile: lipid profile, fasting and post-load glucose and insulin levels, HOMA.
- Liver histology (repeated liver biopsy after 1 year).
- Soluble TNF receptors- TNF-receptor P55 and P75.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ALT > 2 times normal range.
- Liver histology revealing non-alcoholic steatohepatitis [NASH] (type 2-4), without cirrhosis.
- Clinical characteristics of the metabolic syndrome as defined by the National Cholesterol Education Program (NCEP), but no overt diabetes.
- Negative work-up for other causes of liver diseases including alcohol intake < 40 g/week.
Key exclusion criteria (2 listed)
- Diabetes mellitus.
- Alcohol intake > 40 g per week.
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 |
|---|---|---|
| Metformin | Drug | – |
Primary outcome
histological and biochemical changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2006.
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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.
Stephen D Malnick, MD study director
Kaplan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Liver Diseases, run by Kaplan Medical Center at 1 site in Israel.
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 4 inclusion and 2 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 9 Oct 2006. 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 Israel. 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 Hila Knobler, MD (08-9441650, knobler@inter.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histological and biochemical changes. 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 9 Oct 2006.