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Fatty LiverPhase 2/3NCT00303537

Metformin in Non-Alcoholic Fatty Liver Disease

A Phase 2/3 study testing metformin in people with Fatty Liver, run by University Hospital, Aker at 4 sites in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Fatty Liver
What is being tested?
metformin
How many people
90 participants
Where
4 sitesNorway
Study dates
Nov 2004to Jun 2008
Phase
Phase 2/3
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven NAFLD less than 18 months prior to inclusion. For those with pure steatosis, ALAT or aspartate aminotransferase (ASAT) must be elevated above the upper limits of normal, and impaired glucose tolerance or diabetes mellitus type 2 must be present.
  • Body weight within +/- 5 kg compared with the weight at the time of biopsy.

Who cannot join

  • Treatment for more than 1 week with metformin or glitazones the last 6 months before inclusion.
  • Treatment with insulin.
  • Hypersensitivity to metformin.
  • Treatment with cimetidine.
  • Heart failure requiring pharmacological treatment.
  • Coronary heart disease (New York Heart Association [NYHA] class 3 or 4).
Show all 24Show fewer
  • Chronic obstructive lung disease (moderate or severe).
  • Breast-feeding or pregnant.
  • Metabolic acidosis.
  • Renal failure (male [♂]: creatinine > 135 micromol/L, female [♀] > 110 micromol/L).
  • Average alcohol consumption > 24 g/day the last year.
  • Serum ALAT or serum ASAT > 5 x upper limit of normal (ULN) at screening.
  • Cirrhosis.
  • Platelets < 100 000.
  • Haemochromatosis.
  • Alfa-1-antitrypsin-deficiency.
  • Wilson's disease.
  • Thyroid dysfunction (0.2 mU/L < thyroid stimulating hormone [TSH] < 5.0 mU/L).
  • Chronic infection with hepatitis B or C virus or HIV.
  • Autoimmune hepatitis (antinuclear antibodies [ANA] > 1/256 or smooth muscle antibodies [SMA] > 1/128).
  • Primary biliary cirrhosis (antimitochondrial antibodies [AMA] > 1/64).
  • Primary sclerosing cholangitis.
  • Previous participation in another clinical trial the last 6 months.
  • Legal incapability.

Trial locations and contacts

4 sites in 1 country.

Norway4 sites

  • Haukeland Universitetssykehus

    Bergen

  • Aker University Hospital

    Oslo

  • Akershus University Hospital

    Oslo

  • Universitetssykehuset i Nord-Norge

    Tromsø

Other trials in Norway

About this study

Official title: Double Blind, Randomized, Placebo Controlled Trial With Metformin in Non-Alcoholic Fatty Liver Disease (NAFLD)

The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease.

Read the detailed description

Nonalcoholic fatty liver disease (NAFLD) is a prevalent disorder associated with insulin resistance. Metformin is a drug that has been used for several decades in the treatment of diabetes mellitus. Metformin is known to improve insulin sensitivity. Some authors have reported beneficial effects of metformin in NAFLD, others have not been able to reproduce these findings. Only a few randomized controlled studies have been published so far, and there is still need for controlled trials with sufficient power to assess the efficacy of metformin in this condition.

The aim of this study is to see whether treatment with metformin for 26 weeks results in reduction of liver steatosis (primary endpoint) and reduction in grade of inflammation in those with non-alcoholic steatohepatitis (NASH) (secondary endpoint).

Conditions
Fatty Liver
Being tested
metformin
Keywords
hepatitis, metformin, non-alcoholic fatty liver (NAFLD), non-alcoholic steatohepatitis (NASH), Nonalcoholic fatty liver disease
Medical subject headings
Fatty Liver, Hepatitis, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grade of steatosis as judged by repeat biopsy

    Measured: 6 mo

Secondary outcomes (3)

  1. Grade of necroinflammation as judged by repeat biopsy

    Measured: 6 mo

  2. Liver density obtained by computer scan

    Measured: 6 mo

  3. Serum alanine transaminase (ALAT)

    Measured: 6 mo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2006 (estimated)
  2. Study startNov 2004
  3. Study completionJun 2008 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303537
Sponsor's protocol ID
AkerU3
Status last verified
Jun 2007
First submitted
16 Mar 2006
Last updated
2 Jul 2007
Results posted
No
Data monitoring committee
No

Publications

  • Haukeland JW, Dahl TB, Yndestad A, Gladhaug IP, Loberg EM, Haaland T, Konopski Z, Wium C, Aasheim ET, Johansen OE, Aukrust P, Halvorsen B, Birkeland KI. Fetuin A in nonalcoholic fatty liver disease: in vivo and in vitro studies. Eur J Endocrinol. 2012 Mar;166(3):503-10. doi: 10.1530/EJE-11-0864. Epub 2011 Dec 14.

    PubMed 22170794

  • Haukeland JW, Konopski Z, Eggesbo HB, von Volkmann HL, Raschpichler G, Bjoro K, Haaland T, Loberg EM, Birkeland K. Metformin in patients with non-alcoholic fatty liver disease: a randomized, controlled trial. Scand J Gastroenterol. 2009;44(7):853-60. doi: 10.1080/00365520902845268.

    PubMed 19811343

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing metformin in people with Fatty Liver, run by University Hospital, Aker at 4 sites in Norway.

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 2 inclusion and 24 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 2 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Norway. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grade of steatosis as judged by repeat biopsy (time frame: 6 mo). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303537, which also lists 2 linked publications.

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 2 Jul 2007.

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