NCT00247117

Brief 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.

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
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

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

January 1, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
Last Updated

October 9, 2006

Status Verified

October 1, 2003

First QC Date

October 31, 2005

Last Update Submit

October 6, 2006

Conditions

Liver Diseases

Keywords

non-alcoholic fatty liver diseaseinsulin resistancemetformin

Outcome Measures

Primary Outcomes (1)

  • histological and biochemical changes

Interventions

MetforminDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Diabetes mellitus.
  • Alcohol intake \> 40 g per week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Endocrinology, Kaplan Medical Center

Rehovot, 76100, Israel

RECRUITING

MeSH Terms

Conditions

Liver DiseasesNon-alcoholic Fatty Liver DiseaseInsulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Digestive System DiseasesFatty LiverHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Stephen D Malnick, MD

    Kaplan Medical Center

    STUDY DIRECTOR

Central Study Contacts

Hila Knobler, MD

CONTACT

08-9441650knobler@inter.net.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 1, 2005

Study Start

January 1, 2004

Study Completion

August 1, 2005

Last Updated

October 9, 2006

Record last verified: 2003-10

Locations

IL(1)