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Trial registered on ANZCTR


Registration number
ACTRN12609000221257
Ethics application status
Not yet submitted
Date submitted
15/04/2009
Date registered
1/05/2009
Date last updated
1/05/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of the non-invasive evaluation of non-alcoholic fatty liver disease and liver fibrosis in patients with type 2 diabetes mellitus using Fibroscan
Scientific title
A study of the non-invasive evaluation of non-alcoholic fatty liver disease and liver fibrosis in patients with type 2 diabetes mellitus using Fibroscan
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 4594 0
Liver fibrosis 4596 0
Condition category
Condition code
Metabolic and Endocrine 4889 4889 0 0
Diabetes
Oral and Gastrointestinal 4892 4892 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Transient elastography(T.E)- liver stiffness which equates to liver fibrosis will be measured using T.E. T.E is an ultrasound like device which is placed over the liver and sends a vibration through the liver.The quicker the vibration passes through the liver the more fibrosed (or stiff) the liver is. It is a painless procedure lasting 10 minutes approximately.There are no associated adverse events.A total of 3 fibroscansessions will take place on each patient.The first at baseline then at 12 months,then at 24months. Readings are measured in kilopascals.
Participants who have had liver biopsies in the past 12 months will have their T.E measurements compared to the biopsy result.
Participants who have T.E readings indicating significant liver fibrosis(>7.5 Kilopascals) will be offered a liver biopsy to assess the severity of their liver disease if they have not had one in the last 12 months.Liver biopsy will be performed only once in these patients after the baseline transient elastography exam.Patients for liver biopsy will be admitted to the Alfred hospital medical day unit and taken to the radiology department.Liver biopsy will be carried out using local anaesthetic to the right lower rib spaces and sedation(midazolam).Ultrasound guidance will be used and a liver biopsy needle passed into the liver.Patients will be observed after the procedure in the medical day unit for 4 hours.A friend or family member will be requested to take the patient home
Intervention code [1] 4474 0
Not applicable
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5742 0
To examine the prevalence of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus.
NAFLD is defined as the presence of hepatic fatty infiltration on ultrasound associated with elevation of serum Gamma-glutamyltransferase(GGT) levels and/or serum Alanine transaminase(ALT) levels in the absence of other causes for elevated liver function tests(LFTs).It also includes an intake of alcohol < 40 gm per day in males , and < 20 gm/day in females. This will be calculated only once on all patients who will have ultrasounds and liver function blood tests within 3 months of the study start-up as part of their routine standard of care. Alcohol intake history will be collected in a questionnaire during an interview with a researcher.The percentage of the study population who reach the criteria for NAFLD will be calculated(prevalence)
Timepoint [1] 5742 0
From initial recruitment of participants.This outcome will only be measured once at the patient's baseline initial assessment
Primary outcome [2] 5743 0
To evaluate the prevalence of significant liver fibrosis in patients with type 2 diabetes using fibroscan and non-invasive serum markers of fibrosis.Significant liver fibrosis is defined as having >7.5Kpa on fibroscan. The definition of significant liver fibrosis according to serum markers will vary for each marker
Timepoint [2] 5743 0
This outcome will be measured at baseline and then again at 12 and 24 months
Secondary outcome [1] 241690 0
To evaluate the accuracy of fibroscan and non-invasive serum markers for the diagnosis of liver fibrosis when compared to liver biopsy in individuals with type 2 diabetes mellitus associated with non-alcoholic fatty liver disease. Fibroscan categorises liver fibrosis according to Kpa score(F0-1<7.5,F2 >7.5 <9.5 ,F3 >9.5 <13.5,F4>13.5),where F is the stage of fibrosis. These readings equate to the metavir(F) liver biopsy grading system.Using liver biopsy as the gold standard results will be compared to assess for accuracy of fibroscan for predicting liver fibrosis.Serum fibrosis markers will be assessed in a similiar manner.Using sensitivity and specificity we will attempt to validate these non invasive techniques using Area Under the Reicever operator curves
Timepoint [1] 241690 0
This outcome will be measured at baseline only
Secondary outcome [2] 241691 0
To examine the utility of Fibroscan as a screening tool for the presence of non-alcoholic steatohepatitis (NASH) in patients with type 2 diabetes mellitus. Patients who have >7.5kpa on fibroscan will be offered liver biopsy as their fibroscan has indicated significant liver fibrosis.We expect these patients will have a more advanced form of NAFLD in the form of NASH, a histological diagnosis. We will calculate the positive predictive value of fibroscan for detecting NASH on their biopsies in this group(>7.5 kpa and accepting of liver biopsy)
Timepoint [2] 241691 0
This outcome will be measured at baseline only
Secondary outcome [3] 241692 0
To evaluate the progression of liver fibrosis in patients with type 2 diabetics with NAFLD and to compare the rates of fibrosis progression(over time) as measured by fibroscan in patients treated with thiazolidinedione agents and/or metformin compared to those managed by other oral anti-diabetic agents (sulfonylureas, acarbose).This will be evaluated using multivariate analysis. Patients will be divided into groups depending on their routine care oral hypoglycaemic agent and non invasive fibrosis markers (fibroscan and serum fibrosis markers) will be monitored (serially)over a two year period(baseline,12 months,24 months).
Timepoint [3] 241692 0
This outcome will be measured at baseline and at 12 and 24 months

Eligibility
Key inclusion criteria
Type 2 diabetes
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Body Mass Index(BMI)>35
Bleeding disorder
Creatinine>200
International Normalised Ratio(INR)>1.5
Platelets<75
Anti-platelet agent use
Major medical co-morbidities

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4781 0
Hospital
Name [1] 4781 0
The Alfred Hospital
Country [1] 4781 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
Gastroenterology unit
4th floor,
Commercial road ,
Prahran, Vic 3181
Country
Australia
Secondary sponsor category [1] 4316 0
None
Name [1] 4316 0
Address [1] 4316 0
Country [1] 4316 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6827 0
Alfred Health
Ethics committee address [1] 6827 0
Ethics committee country [1] 6827 0
Australia
Date submitted for ethics approval [1] 6827 0
27/04/2009
Approval date [1] 6827 0
Ethics approval number [1] 6827 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29487 0
Address 29487 0
Country 29487 0
Phone 29487 0
Fax 29487 0
Email 29487 0
Contact person for public queries
Name 12734 0
Dr Stephen Casey
Address 12734 0
Gastroenterology unit,
4th floor,
Commercial road ,
Prahran, Vic 3181
Country 12734 0
Australia
Phone 12734 0
+61 3 9076 2223/+61 450 378 005
Fax 12734 0
Email 12734 0
s.casey@alfred.org.au
Contact person for scientific queries
Name 3662 0
Dr Stephen Casey
Address 3662 0
Gastroenterology unit,
4th floor,
Commercial road ,
Prahran, Vic 3181
Country 3662 0
Australia
Phone 3662 0
+61 3 9076 2223/+61 450 378 005
Fax 3662 0
Email 3662 0
s.casey@alfred.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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