NCT00303537

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2004

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

July 2, 2007

Status Verified

June 1, 2007

First QC Date

March 16, 2006

Last Update Submit

June 29, 2007

Conditions

Fatty Liver

Keywords

hepatitismetforminnon-alcoholic fatty liver (NAFLD)non-alcoholic steatohepatitis (NASH)Nonalcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

  • Grade of steatosis as judged by repeat biopsy

    6 mo

Secondary Outcomes (3)

  • Grade of necroinflammation as judged by repeat biopsy

    6 mo

  • Liver density obtained by computer scan

    6 mo

  • Serum alanine transaminase (ALAT)

    6 mo

Interventions

metforminDRUG

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body weight within +/- 5 kg compared with the weight at the time of biopsy.

You may not qualify if:

  • 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).
  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Haukeland Universitetssykehus

Bergen, Norway

Location

Aker University Hospital

Oslo, Norway

Location

Akershus University Hospital

Oslo, Norway

Location

Universitetssykehuset i Nord-Norge

Tromsø, Norway

Location

Related Publications (2)

  • 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.

    PMID: 22170794DERIVED

  • 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.

    PMID: 19811343DERIVED

MeSH Terms

Conditions

Fatty LiverHepatitisNon-alcoholic Fatty Liver Disease

Interventions

Metformin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Kaare Birkeland, Prof./Ph.D

    Aker University Hospital, Oslo, Norway

    STUDY CHAIR

  • Zbigniew Konopski, Cons./Ph.D

    Aker University Hospital, Oslo, Norway

    STUDY CHAIR

  • Kristian Bjøro, Cons./Ph.D

    Rikshospitalet-Radiumhospitalet, Oslo, Norway

    STUDY CHAIR

  • John W Haukeland, Physician

    University Hospital, Aker

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

November 1, 2004

Study Completion

June 1, 2008

Last Updated

July 2, 2007

Record last verified: 2007-06

Locations

NO(4)