This study is designed to investigate whether the sodium-glucose co-transporter-2 (SGLT-2) inhibitor Empagliflozin reduces sympathetic nervous system (SNS) activity in humans.
This is a randomised, double-blind, placebo controlled, cross-over study. Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo and will later receive the alternate treatment. Comprehensive testing will occur after each 4 week treatment phase and will include assessment of muscle sympathetic nerve activity, cardiac and renal noradrenaline spillover to assess organ specific SNS activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
30
Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo 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 4-week treatment phases will be separated by a 4-week wash out (drug-free) period. The study will consist of a total of 5 visits conducted over approximately 18 weeks; one screening visit, one baseline visit, 1 short visit at the start of the second treatment phase and 2 comprehensive testing visits, each at the end of the two treatment phases
Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo 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 4-week treatment phases will be separated by a 4-week wash out (drug-free) period. The study will consist of a total of 5 visits conducted over approximately 18 weeks; one screening visit, one baseline visit, 1 short visit at the start of the second treatment phase and 2 comprehensive testing visits, each at the end of the two treatment phases
Royal Perth Hospital
Perth, Western Australia, Australia
RECRUITINGReduction in cardiac sympathetic nerve activity
Cardiac sympathetic nerve activity assessed by cardiac noradrenaline spillover
Time frame: 18 weeks
Reduction in renal sympathetic nerve activity
Renal sympathetic nerve activity assessed by renal noradrenaline spillover
Time frame: 18 weeks
Reduction in muscle sympathetic nerve activity
Muscle sympathetic nerve activity assessed by microneurography
Time frame: 18 weeks
Reduction in ambulatory BP (blood pressure)
Blood Pressure assessed by ambulatory blood pressure monitoring
Time frame: 18 weeks
Reduction in central Blood Pressure
central Blood Pressure assessed by Sphygmocor XCEL
Time frame: 18 weeks
Change in urinary sodium excretion
Urinary sodium excretion assessed in a 24 hour urine sample
Time frame: 18 weeks
Change in glycemic control
Glycemic control as assessed by an oral glucose tolerance test
Time frame: 18 weeks
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