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

Royal Perth Hospital

Status and phase: Enrolling; Phase 4

Conditions: Type 2 Diabetes Mellitus; Obesity; Metabolic Syndrome

Treatments: Drug: Placebo Oral Tablet; Drug: Empagliflozin Oral Tablet [Jardiance]

Study type: Interventional

Funder types: Other

Identifiers

NCT03912909

REG 16-157

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Phase 1

Active Comparator group

Description:

Empagliflozin 10mg daily or placebo

Treatment:

Drug: Placebo Oral Tablet

Drug: Empagliflozin Oral Tablet [Jardiance]

Phase2

Placebo Comparator group

Description:

Empagliflozin 10mg daily or placebo

Treatment:

Drug: Placebo Oral Tablet

Drug: Empagliflozin Oral Tablet [Jardiance]