| Trial ID: | L6280 |
| Source ID: | NCT03912909
|
| Associated Drug: |
Empagliflozin Oral Tablet [Jardiance]
|
| Title: |
Effects of Sodium-glucose Co-transporter-2( SGLT-2 ) Inhibition on Sympathetic Nervous System Activity in Humans
|
| Acronym: |
EMPA-SNS
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Metabolic Syndrome|Type 2 Diabetes Mellitus|Obesity
|
| Interventions: |
DRUG: Empagliflozin Oral Tablet [Jardiance]|DRUG: Placebo Oral Tablet
|
| Outcome Measures: |
Primary: Reduction in cardiac sympathetic nerve activity, Cardiac sympathetic nerve activity assessed by cardiac noradrenaline spillover, 18 weeks|Reduction in renal sympathetic nerve activity, Renal sympathetic nerve activity assessed by renal noradrenaline spillover, 18 weeks|Reduction in muscle sympathetic nerve activity, Muscle sympathetic nerve activity assessed by microneurography, 18 weeks | Secondary: Reduction in ambulatory BP (blood pressure), Blood Pressure assessed by ambulatory blood pressure monitoring, 18 weeks|Reduction in central Blood Pressure, central Blood Pressure assessed by Sphygmocor XCEL, 18 weeks|Change in urinary sodium excretion, Urinary sodium excretion assessed in a 24 hour urine sample, 18 weeks|Change in glycemic control, Glycemic control as assessed by an oral glucose tolerance test, 18 weeks
|
| Sponsor/Collaborators: |
Sponsor: Royal Perth Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2018-08-01
|
| Completion Date: |
2024-12-30
|
| Results First Posted: |
|
| Last Update Posted: |
2022-09-29
|
| Locations: |
Royal Perth Hospital, Perth, Western Australia, 6000, Australia
|
| URL: |
https://clinicaltrials.gov/show/NCT03912909
|
