The effect of moxonidine on non-alcoholic fatty liver disease

The effect of moxonidine on liver fat quantification in patients with non-alcoholic fatty liver disease

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000948392

Enrollment

100

Registered

2017-07-03

Start date

2017-07-10

Completion date

2020-07-10

Last updated

2017-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 .

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with non-alcoholic fatty liver disease, patients with varying degrees of hepatic steatosis, inflammation and fibrosis will also be included.

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.

Outcome results