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

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Perth Hospital
• Treatments: Empagliflozin

Criteria

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