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

September 28, 2022 updated by: Dr Markus Schlaich, Royal Perth Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Royal Perth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Phase 1
Empagliflozin 10mg daily or placebo
Drug: 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: 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
Placebo Comparator: Phase2
Empagliflozin 10mg daily or placebo
Drug: 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: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Perth Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG 16-157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual Participant Data will not be shared to maintain anonymity and confidentiality of the participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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