Metabolic SyndromePhase 4EMPA-SNSNCT03912909

Effects of Sodium-glucose Co-transporter-2( SGLT-2 ) Inhibition on Sympathetic Nervous System Activity in Humans

A Phase 4 study testing Empagliflozin Oral Tablet [Jardiance] in people with Metabolic Syndrome and Type 2 Diabetes Mellitus, run by Royal Perth Hospital at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 25 to 65 years
Conditions the study is for: Metabolic Syndrome, Type 2 Diabetes Mellitus, Obesity
What is being tested?: Empagliflozin Oral Tablet [Jardiance]
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteAustralia
Study dates: 1 Aug 2018to 30 Dec 2024
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Anu Joyson, MSN contact

+61 8 92240390

anu.joyson@uwa.edu.au

Australia1 site, 1 recruiting

Royal Perth Hospital
Perth, Western Australia, 6000
Anu Joyson, MSC RN, =08 922 ext. 40390, anu.joyson@uwa.edu.au
Markus Schlaich, Prof
Recruiting

Other trials in Australia

About this study

Official title: Effects of SGLT-2 Inhibition on Sympathetic Nervous System Activity in Humans

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.

Read the detailed description

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.

Conditions: Metabolic Syndrome, Type 2 Diabetes Mellitus, Obesity
Being tested: Empagliflozin Oral Tablet [Jardiance], Placebo Oral Tablet
Keywords: Metabolic Syndrome, Central sympathetic nervous system, Sodium-glucose co-transporter-2 (SGLT2), Blood Pressure
Medical subject headings: Metabolic Syndrome, Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Empagliflozin Oral Tablet [Jardiance]Drug
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
Placebo Oral TabletDrug
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

Study groups in NCT03912909
Study group	Role	What they receive
Phase 1	Active comparator	Empagliflozin 10mg daily or placebo Receives: Drug: Empagliflozin Oral Tablet [Jardiance]; Drug: Placebo Oral Tablet
Phase2	Placebo comparator	Empagliflozin 10mg daily or placebo Receives: Drug: Empagliflozin Oral Tablet [Jardiance]; Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in cardiac sympathetic nerve activity
Cardiac sympathetic nerve activity assessed by cardiac noradrenaline spillover
Measured: 18 weeks
Reduction in renal sympathetic nerve activity
Renal sympathetic nerve activity assessed by renal noradrenaline spillover
Measured: 18 weeks
Reduction in muscle sympathetic nerve activity
Muscle sympathetic nerve activity assessed by microneurography
Measured: 18 weeks

Secondary outcomes (4)

Reduction in ambulatory BP (blood pressure)
Blood Pressure assessed by ambulatory blood pressure monitoring
Measured: 18 weeks
Reduction in central Blood Pressure
central Blood Pressure assessed by Sphygmocor XCEL
Measured: 18 weeks
Change in urinary sodium excretion
Urinary sodium excretion assessed in a 24 hour urine sample
Measured: 18 weeks
Change in glycemic control
Glycemic control as assessed by an oral glucose tolerance test
Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201830 Dec 2024

First posted11 Apr 2019
Study start1 Aug 2018
Primary completion31 Mar 2024 (estimated)
Study completion30 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03912909
Sponsor's protocol ID: REG 16-157
Acronym: EMPA-SNS
Status last verified: Sep 2022
First submitted: 23 Oct 2018
Last updated: 29 Sep 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual Participant Data will not be shared to maintain anonymity and confidentiality of the participants

Publications

Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
PubMed 26378978
Hall JE, Jones DW, Kuo JJ, da Silva A, Tallam LS, Liu J. Impact of the obesity epidemic on hypertension and renal disease. Curr Hypertens Rep. 2003 Oct;5(5):386-92. doi: 10.1007/s11906-003-0084-z.
PubMed 12948431
Esler M, Straznicky N, Eikelis N, Masuo K, Lambert G, Lambert E. Mechanisms of sympathetic activation in obesity-related hypertension. Hypertension. 2006 Nov;48(5):787-96. doi: 10.1161/01.HYP.0000242642.42177.49. Epub 2006 Sep 25. No abstract available.
PubMed 17000932
Straznicky NE, Grima MT, Sari CI, Karapanagiotidis S, Wong C, Eikelis N, Richards KL, Lee G, Nestel PJ, Dixon JB, Lambert GW, Schlaich MP, Lambert EA. The relation of glucose metabolism to left ventricular mass and function and sympathetic nervous system activity in obese subjects with metabolic syndrome. J Clin Endocrinol Metab. 2013 Feb;98(2):E227-37. doi: 10.1210/jc.2012-3277. Epub 2012 Dec 27.
PubMed 23271752
Straznicky NE, Lambert EA, Grima MT, Eikelis N, Richards K, Nestel PJ, Dawood T, Masuo K, Sari CI, Dixon JB, Esler MD, Paul E, Schlaich MP, Lambert GW. The effects of dietary weight loss on indices of norepinephrine turnover: modulatory influence of hyperinsulinemia. Obesity (Silver Spring). 2014 Mar;22(3):652-62. doi: 10.1002/oby.20614. Epub 2013 Dec 6.
PubMed 23997009
Schlaich MP, Kaye DM, Lambert E, Sommerville M, Socratous F, Esler MD. Relation between cardiac sympathetic activity and hypertensive left ventricular hypertrophy. Circulation. 2003 Aug 5;108(5):560-5. doi: 10.1161/01.CIR.0000081775.72651.B6. Epub 2003 Jul 7.
PubMed 12847071
Ziegler D, Weise F, Langen KJ, Piolot R, Boy C, Hubinger A, Muller-Gartner HW, Gries FA. Effect of glycaemic control on myocardial sympathetic innervation assessed by [123I]metaiodobenzylguanidine scintigraphy: a 4-year prospective study in IDDM patients. Diabetologia. 1998 Apr;41(4):443-51. doi: 10.1007/s001250050928.
PubMed 9562349
Sverrisdottir YB, Jansson LM, Hagg U, Gan LM. Muscle sympathetic nerve activity is related to a surrogate marker of endothelial function in healthy individuals. PLoS One. 2010 Feb 17;5(2):e9257. doi: 10.1371/journal.pone.0009257.
PubMed 20174639
Mahfoud F, Schlaich M, Kindermann I, Ukena C, Cremers B, Brandt MC, Hoppe UC, Vonend O, Rump LC, Sobotka PA, Krum H, Esler M, Bohm M. Effect of renal sympathetic denervation on glucose metabolism in patients with resistant hypertension: a pilot study. Circulation. 2011 May 10;123(18):1940-6. doi: 10.1161/CIRCULATIONAHA.110.991869. Epub 2011 Apr 25.
PubMed 21518978

Want to know more?

Anu Joyson, MSN

+61 8 92240390

anu.joyson@uwa.edu.au

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of SGLT-2 Inhibition on Sympathetic Nervous System Activity in Humans
ClinicalTrials.gov ID: NCT03912909
Acronym / sponsor ID: EMPA-SNS / REG 16-157
Conditions: Metabolic Syndrome, Type 2 Diabetes Mellitus, Obesity
Keywords: Metabolic Syndrome, Central sympathetic nervous system, Sodium-glucose co-transporter-2 (SGLT2), Blood Pressure
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Royal Perth HospitalUniversity, hospital or other
Study start: 1 Aug 2018 (actual)
Primary completion: 31 Mar 2024 (estimated)
Study completion: 30 Dec 2024 (estimated)
First posted: 11 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Phase 1	Active comparator	Drug: Empagliflozin Oral Tablet [Jardiance], Drug: Placebo Oral TabletEmpagliflozin 10mg daily or placebo
Phase2	Placebo comparator	Drug: Empagliflozin Oral Tablet [Jardiance], Drug: Placebo Oral TabletEmpagliflozin 10mg daily or placebo

Who may qualify

Ages: 25 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Drug	Phase 1, Phase2
Placebo Oral TabletParticipants 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	Drug	Phase 1, Phase2

Primary outcome

Reduction in cardiac sympathetic nerve activity
Time frame: 18 weeks
Cardiac sympathetic nerve activity assessed by cardiac noradrenaline spillover
Reduction in renal sympathetic nerve activity
Time frame: 18 weeks
Renal sympathetic nerve activity assessed by renal noradrenaline spillover
Reduction in muscle sympathetic nerve activity
Time frame: 18 weeks
Muscle sympathetic nerve activity assessed by microneurography

4 secondary outcomes

Reduction in ambulatory BP (blood pressure)
Time frame: 18 weeks
Reduction in central Blood Pressure
Time frame: 18 weeks
Change in urinary sodium excretion
Time frame: 18 weeks
Change in glycemic control
Time frame: 18 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
Background: PubMed 26378978Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
Background: PubMed 12948431Hall JE, Jones DW, Kuo JJ, da Silva A, Tallam LS, Liu J. Impact of the obesity epidemic on hypertension and renal disease. Curr Hypertens Rep. 2003 Oct;5(5):386-92. doi: 10.1007/s11906-003-0084-z.
Background: PubMed 17000932Esler M, Straznicky N, Eikelis N, Masuo K, Lambert G, Lambert E. Mechanisms of sympathetic activation in obesity-related hypertension. Hypertension. 2006 Nov;48(5):787-96. doi: 10.1161/01.HYP.0000242642.42177.49. Epub 2006 Sep 25. No abstract available.
Background: PubMed 23271752Straznicky NE, Grima MT, Sari CI, Karapanagiotidis S, Wong C, Eikelis N, Richards KL, Lee G, Nestel PJ, Dixon JB, Lambert GW, Schlaich MP, Lambert EA. The relation of glucose metabolism to left ventricular mass and function and sympathetic nervous system activity in obese subjects with metabolic syndrome. J Clin Endocrinol Metab. 2013 Feb;98(2):E227-37. doi: 10.1210/jc.2012-3277. Epub 2012 Dec 27.
Background: PubMed 23997009Straznicky NE, Lambert EA, Grima MT, Eikelis N, Richards K, Nestel PJ, Dawood T, Masuo K, Sari CI, Dixon JB, Esler MD, Paul E, Schlaich MP, Lambert GW. The effects of dietary weight loss on indices of norepinephrine turnover: modulatory influence of hyperinsulinemia. Obesity (Silver Spring). 2014 Mar;22(3):652-62. doi: 10.1002/oby.20614. Epub 2013 Dec 6.
Background: PubMed 12847071Schlaich MP, Kaye DM, Lambert E, Sommerville M, Socratous F, Esler MD. Relation between cardiac sympathetic activity and hypertensive left ventricular hypertrophy. Circulation. 2003 Aug 5;108(5):560-5. doi: 10.1161/01.CIR.0000081775.72651.B6. Epub 2003 Jul 7.
Background: PubMed 9562349Ziegler D, Weise F, Langen KJ, Piolot R, Boy C, Hubinger A, Muller-Gartner HW, Gries FA. Effect of glycaemic control on myocardial sympathetic innervation assessed by [123I]metaiodobenzylguanidine scintigraphy: a 4-year prospective study in IDDM patients. Diabetologia. 1998 Apr;41(4):443-51. doi: 10.1007/s001250050928.
Background: PubMed 20174639Sverrisdottir YB, Jansson LM, Hagg U, Gan LM. Muscle sympathetic nerve activity is related to a surrogate marker of endothelial function in healthy individuals. PLoS One. 2010 Feb 17;5(2):e9257. doi: 10.1371/journal.pone.0009257.
Background: PubMed 21518978Mahfoud F, Schlaich M, Kindermann I, Ukena C, Cremers B, Brandt MC, Hoppe UC, Vonend O, Rump LC, Sobotka PA, Krum H, Esler M, Bohm M. Effect of renal sympathetic denervation on glucose metabolism in patients with resistant hypertension: a pilot study. Circulation. 2011 May 10;123(18):1940-6. doi: 10.1161/CIRCULATIONAHA.110.991869. Epub 2011 Apr 25.
Individual participant dataSharing planned: No. Individual Participant Data will not be shared to maintain anonymity and confidentiality of the participants

Related trials for Metabolic Syndrome

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anu Joyson, MSN contact

+61 8 92240390

anu.joyson@uwa.edu.au

Markus Schlaich, MD,FAHA,FESC principal investigator

Royal Perth Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin Oral Tablet [Jardiance] in people with Metabolic Syndrome and Type 2 Diabetes Mellitus, run by Royal Perth Hospital at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anu Joyson, MSN (+61 8 92240390, anu.joyson@uwa.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in cardiac sympathetic nerve activity (time frame: 18 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03912909, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.