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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03912909




Registration number
NCT03912909
Ethics application status
Date submitted
23/10/2018
Date registered
11/04/2019

Titles & IDs
Public title
Effects of Sodium-glucose Co-transporter-2( SGLT-2 ) Inhibition on Sympathetic Nervous System Activity in Humans
Scientific title
Effects of SGLT-2 Inhibition on Sympathetic Nervous System Activity in Humans
Secondary ID [1] 0 0
REG 16-157
Universal Trial Number (UTN)
Trial acronym
EMPA-SNS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 0 0
Type 2 Diabetes Mellitus 0 0
Obesity 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Empagliflozin Oral Tablet [Jardiance]
Treatment: Drugs - Placebo Oral Tablet

Active comparator: Phase 1 - Empagliflozin 10mg daily or placebo

Placebo comparator: Phase2 - Empagliflozin 10mg daily or placebo


Treatment: Drugs: Empagliflozin Oral Tablet [Jardiance]
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

Treatment: Drugs: Placebo Oral Tablet
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in cardiac sympathetic nerve activity
Timepoint [1] 0 0
18 weeks
Primary outcome [2] 0 0
Reduction in renal sympathetic nerve activity
Timepoint [2] 0 0
18 weeks
Primary outcome [3] 0 0
Reduction in muscle sympathetic nerve activity
Timepoint [3] 0 0
18 weeks
Secondary outcome [1] 0 0
Reduction in ambulatory BP (blood pressure)
Timepoint [1] 0 0
18 weeks
Secondary outcome [2] 0 0
Reduction in central Blood Pressure
Timepoint [2] 0 0
18 weeks
Secondary outcome [3] 0 0
Change in urinary sodium excretion
Timepoint [3] 0 0
18 weeks
Secondary outcome [4] 0 0
Change in glycemic control
Timepoint [4] 0 0
18 weeks

Eligibility
Key inclusion criteria
* Age: 25 -65 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)
* Metabolic syndrome (defined as having: obesity (BMI =30kg/m2 ) plus any two of the following four factors: Elevated triglycerides (Triglyceride= 1.7mmol/L), Reduced HDL (High - density lipoprotein) cholesterol (<1.0mmol/L in males, <1.3mmol/L in females), Elevated clinic systolic (Blood Pressure) BP =130 or diastolic BP =85mmHg, Fasting glucose =5.6mmol/L or type 2 diabetes.
* office BP for screening purposes =160/90mmHg
* drug naïve for at least 6 weeks prior to baseline assessment
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Perth Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus Schlaich, MD,FAHA,FESC
Address 0 0
Royal Perth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anu Joyson, MSN
Address 0 0
Country 0 0
Phone 0 0
+61 8 92240390
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual Participant Data will not be shared to maintain anonymity and confidentiality of the participants


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03912909