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Trial registered on ANZCTR


Registration number
ACTRN12617000948392
Ethics application status
Approved
Date submitted
27/06/2017
Date registered
3/07/2017
Date last updated
3/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of moxonidine on non-alcoholic fatty liver disease
Scientific title
The effect of moxonidine on liver fat quantification in patients with non-alcoholic fatty liver disease
Secondary ID [1] 292294 0
Nil known
Universal Trial Number (UTN)
U1111-1198-3949
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fatty liver disease 303818 0
Condition category
Condition code
Oral and Gastrointestinal 303186 303186 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active drug = moxonidine capsules 0.2mg once daily for 2 weeks, then up titration to 0.2mg twice daily for 3 months
Return tablets will be counted to assess participants' compliance.
Intervention code [1] 298470 0
Treatment: Drugs
Comparator / control treatment
Placebo is lactose powder, 1 capsule daily for 2 weeks, then to 2 capsules daily for 3 months.
Control group
Placebo

Outcomes
Primary outcome [1] 302571 0
5% post baseline change in MRI assessed fat quantification in the liver
Timepoint [1] 302571 0
3 months post baseline
Primary outcome [2] 302572 0
HOMA index difference between the groups of 20%
Timepoint [2] 302572 0
3 months postbaseline
Secondary outcome [1] 336390 0
Difference in muscle sympathetic nerve activity (MSNA) between the groups assessed using microneurography technique.
Timepoint [1] 336390 0
3 months post baseline
Secondary outcome [2] 336391 0
30% change in Alanine Aminotransferase (ALT) between the groups assessed via pathology assay
Timepoint [2] 336391 0
3 months post baseline
Secondary outcome [3] 336392 0
Changes in liver stiffness measured via fibroscan.
Timepoint [3] 336392 0
3 months post baseline
Secondary outcome [4] 336393 0
Changes in Liver function test as measured via serum assay
Timepoint [4] 336393 0
3 months post baseline
Secondary outcome [5] 336394 0
Changes in serum cytokeratin 18 fragments
Timepoint [5] 336394 0
3 months post baseline
Secondary outcome [6] 336395 0
changes in adipokine measured via ELISA assay
Timepoint [6] 336395 0
3 months post baseline
Secondary outcome [7] 336396 0
Changes in anthropometric measurement between the group (composite of weight, waist circumference, waist-to-hip ratio and body composition analysis from DXA scan) between the groups
Timepoint [7] 336396 0
3 months post baseline
Secondary outcome [8] 336397 0
Changes in patient-reported quality of life (SF-36 v2) between the groups
Timepoint [8] 336397 0
3 months post baseline
Secondary outcome [9] 336494 0
changes in liver steatosis as measured via fibroscan
Timepoint [9] 336494 0
3 months post baseline
Secondary outcome [10] 336495 0
Changes in fasting glucose level
Timepoint [10] 336495 0
3 months post baseline
Secondary outcome [11] 336496 0
Changes in lipid profiles (composite of Low density lipoprotein, high density lipoprotein, total cholesterol and triglycerides)
Timepoint [11] 336496 0
3 months post baseline

Eligibility
Key inclusion criteria
Patients with non-alcoholic fatty liver disease, patients with varying degrees of hepatic steatosis, inflammation and fibrosis will also be included.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concurrent liver disease, non-English speaking, inability to give consent, average weekly alcohol consumption > 140g for females and >210g for males, past history of cerebrovascular or peripheral vascular disease; presence of clinically relevant pulmonary, gastro-intestinal, renal, haemotological, neruological, psychiatric, systemic or any acute infectious disease or signs of acute illness; women who are pregnant or currently breastfeeding; gastrointestinal (malabsorptive conditions e.g. coeliac disease) or psychosocial contraindications such as bulimia nervosa, substance abuse, depression, or current psychiatric care; ; recent (within 3months of screening visit) change in dose/regimen or introduction of pioglitazone, metformin, Vitamin E, Vitamin C or high dose Vitamin D, fish oil or probiotics; current participation in any other clinical study targeting diet and lifestyle factors; participant is lactose intolerant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting clinical trial pharmacy of Alfred hospital which is off-site. Clinical trial pharmacy will then allocate the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
. A sample size of 43 subjects per treatment arm will have an 80% power to demonstrate a difference in HOMA-IR of 20% or greater (a = 0.05). This is based on our data indicating that HOMA-IR in subjects with the metabolic syndrome (n=76) is 4.1 (standard deviation 1.35). 100 subjects will be recruited to allow for procedural failure and to account projected withdrawal rate of 14%.

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

Funding & Sponsors
Funding source category [1] 296838 0
Government body
Name [1] 296838 0
NHMRC
Address [1] 296838 0
Research Committee Secretariat NHMRC
GPO Box 1421 Canberra ACT 2601
Country [1] 296838 0
Australia
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
75 Commercial Road, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 295832 0
Other Collaborative groups
Name [1] 295832 0
Monash Health
Address [1] 295832 0
Level 2, I Block, Monash Health
246 Clayton Road
Clatyon VIC 3168
Country [1] 295832 0
Australia
Secondary sponsor category [2] 295834 0
Other Collaborative groups
Name [2] 295834 0
Alfred Health
Address [2] 295834 0
55 Commercial Road
Melbourne VIC 3004
Country [2] 295834 0
Australia
Secondary sponsor category [3] 295835 0
Other Collaborative groups
Name [3] 295835 0
Iverson Health Innovation Research Institute
Address [3] 295835 0
PO Box 218, HAWTHORN, VIC, 3122
Country [3] 295835 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298070 0
Alfred Health Ethics committee
Ethics committee address [1] 298070 0
55 Commercial Road
Melbourne, VIC 3004
Ethics committee country [1] 298070 0
Australia
Date submitted for ethics approval [1] 298070 0
02/03/2017
Approval date [1] 298070 0
20/06/2017
Ethics approval number [1] 298070 0

Summary
Brief summary
Currently there is no proven effective medication to combat fatty liver disease. The aim of this study is to determine whether sympathetic nervous system (SNS) function is linked to liver disease. The study will help to investigate how “overly-active” your SNS in the presence of liver disease and whether there is an association between liver fat quantity and the SNS’s degree of overactivity. Finally, we would like to see if an “SNS-blocking agent” which could reduce your SNS activity could have a favourable impact on your liver and general metabolism. The “SNS-blocking agent” that we will use in this research project is called moxonidine .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75894 0
Prof Gavin Lambert
Address 75894 0
Iverson Health Innovation Research Institute
Faculty of Health, Arts and Design, Swinburne University of Technology
PO Box 218, HAWTHORN, VIC, 3122
Country 75894 0
Australia
Phone 75894 0
+61 3 92148040
Fax 75894 0
Email 75894 0
glambert@swin.edu.au
Contact person for public queries
Name 75895 0
Ms Carolina Sari
Address 75895 0
Baker Heart and Diabetes Institute
75 Commercial Road
Melbourne, VIC 3004
Country 75895 0
Australia
Phone 75895 0
+61 3 8532 1163
Fax 75895 0
Email 75895 0
carolinaika.sari@baker.edu.au
Contact person for scientific queries
Name 75896 0
Prof Gavin Lambert
Address 75896 0
Iverson Health Innovation Research Institute
Faculty of Health, Arts and Design, Swinburne University of Technology
PO Box 218, HAWTHORN, VIC, 3122
Country 75896 0
Australia
Phone 75896 0
+61 3 92148040
Fax 75896 0
Email 75896 0
glambert@swin.edu.au

No data has been provided for results reporting
Summary results
Not applicable