Obesity, Hypertension
Conditions
Brief summary
This study is designed to investigate whether sympathoinhibition with moxonidine could provide added metabolic benefit compared to the second line therapy in the current guidelines.
Detailed description
This is a randomised, double-blind, cross-over study. Participants will be randomly assigned to receive either moxonidine 0.4mg daily or amlodipine 5mg and will later receive the alternate treatment. Comprehensive testing will occur after each 12 week treatment phase and will include assessment of muscle sympathetic nerve activity, gut microbiome analysis and metabolic markers.
Interventions
DRUGMoxonidine 0.4 MG
Participants will be randomly assigned to receive moxonidine 0.4mg/daily and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.
DRUGAmlodipine 5mg
Participants will be randomly assigned to receive amlodipine 5mg and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.
Sponsors
The University of Western Australia
Royal Perth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double (Participant, Investigator)
Intervention model description
Randomized, double blind cross over study
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age: 25 -70 years * (Body Mass Index) BMI≥30kg/m2 * Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program) * Elevated clinic systolic (Blood Pressure) BP ≥135 or diastolic BP ≥85mmHg, * on ACE inhibitor for at least 6 weeks prior to baseline assessment
Exclusion criteria
* Grade 2-3 hypertension (systolic office BP \>160, diastolic office BP \>100 mmHg) * Secondary causes of hypertension * CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR\<30ml/min} * Heart failure NYHA (New York Heart Association) class II-IV * Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months) unstable psychiatric condition * medication such as corticosteroids, several antidepressants and antipsychotics * Female participants of childbearing potential must have a negative pregnancy test prior to treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 30 weeks | Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood glucose levels | 30 weeks | Changes in glycemic control through oral glucose tolerance test |
| Gut microbiota profile | 30 weeks | Change in gut microbiota assessed by short chain fatty acid |
| Lipid levels in blood | 30 weeks | change in triglyceride, HDL and LDL levels in blood |
Countries
Australia
Contacts
Primary ContactRevathy Carnagarin, MD
Backup ContactAnu Joyson, MSN
Outcome results
None listed