| Trial ID: | L0995 |
| Source ID: | ACTRN12617000948392
|
| Associated Drug: |
Moxonidine
|
| Title: |
The effect of moxonidine on liver fat quantification in patients with non-alcoholic fatty liver disease
|
| Acronym: |
--
|
| Status: |
Not yet recruiting
|
| Study Results: |
--
|
| Results: |
--
|
| Conditions: |
fatty liver disease
|
| Interventions: |
Active drug = moxonidine capsules 0.2mg once daily for 2 weeks, then up titration to 0.2mg twice daily for 3 months
|
| Outcome Measures: |
5% post baseline change in MRI assessed fat quantification in the liver
Timepoint [1]
3 months post baseline
Primary outcome [2]
HOMA index difference between the groups of 20%
Timepoint [2]
3 months postbaseline
Secondary outcome [1]
Difference in muscle sympathetic nerve activity (MSNA) between the groups assessed using microneurography technique.
Timepoint [1]
3 months post baseline
Secondary outcome [2]
30% change in Alanine Aminotransferase (ALT) between the groups assessed via pathology assay
Timepoint [2]
3 months post baseline
Secondary outcome [3]
Changes in liver stiffness measured via fibroscan.
Timepoint [3]
3 months post baseline
Secondary outcome [4]
Changes in Liver function test as measured via serum assay
Timepoint [4]
3 months post baseline
Secondary outcome [5]
Changes in serum cytokeratin 18 fragments
Timepoint [5]
3 months post baseline
Secondary outcome [6]
changes in adipokine measured via ELISA assay
Timepoint [6]
3 months post baseline
Secondary outcome [7]
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]
3 months post baseline
Secondary outcome [8]
Changes in patient-reported quality of life (SF-36 v2) between the groups
Timepoint [8]
3 months post baseline
Secondary outcome [9]
changes in liver steatosis as measured via fibroscan
Timepoint [9]
3 months post baseline
Secondary outcome [10]
Changes in fasting glucose level
Timepoint [10]
3 months post baseline
Secondary outcome [11]
Changes in lipid profiles (composite of Low density lipoprotein, high density lipoprotein, total cholesterol and triglycerides)
Timepoint [11]
3 months post baseline
|
| Sponsor/Collaborators: |
NHMRC
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 4
|
| Enrollment: |
--
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation involves contacting clinical trial pharmacy of Alfred hospital which is off-site. Clinical trial pharmacy will then allocate the participant.
|
| Start Date: |
3/07/2017
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
3/07/2017
|
| Locations: |
Australia
|
| URL: |
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000948392
|
