A study examining the effects of empagliflozin (Jardiance®), a tablet for treatment of diabetes on autonomic nervous system and heart function in patients with type 2 diabetes.

Phase 4

Recruiting

• Conditions: Type 2 Diabetes; Metabolic and Endocrine - Diabetes; Cardiovascular - Normal development and function of the cardiovascular system

• Registration Number: ACTRN12619000887178
• Lead Sponsor: Baker Heart and Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-26
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Adults with established Type 2 diabetes > 12 months on any anti-hyperglycaemic agents except for SGLT-2 inhibitors
- HbA1c 7.1-10.0%
- Estimated glomerular filtration rate (e-GFR) > 45 ml/min

Exclusion Criteria

- History of sodium glucose transporter-2 (SGLT2) inhibitor treatment in the past 3 months or intolerance
- Age > 75 years
- Known heart failure or established cardiac disease
- Treatment with beta blockers or centrally acting sympathetic blockers
- Unable to perform moderate cycloergometric exercise
- Chronic kidney disease stage IIIB or above (e-GFR <45)
- History of recurrent genital infections and Urinary Tract Infections
- Hypoglycaemia requiring third party assistance in the previous 3 months
euglycaemic diabetic ketoacidosis in the previous 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in VO2peak from baseline in patients with type 2 diabetes taking empagliflozin compared with placebo.<br>A ramp protocol peak exercise test will be performed on a bicycle ergometer to assess VO2peak[Baseline and 3 months ];Change in muscle sympathetic nerve activity (MSNA) from baseline in patients with type 2 diabetes taking empagliflozin compared with placebo.<br>Resting multiunit MSNA activity will be measured by microneurography via a tungsten microelectrode inserted into a muscle nerve fascicle of the right peroneal nerve.[Baseline and 3 months]

Secondary Outcome Measures

Name	Time	Method
Changes in Ventilatory efficiency (VE/VCO2 slope) from baseline in patients taking empagliflozin compared with placebo.<br>Analysis of VE and VCO2 will be conducted using metabolic cart. VE and VCO2 responses throughout exercise will be used to calculate the VE/VCO2 slope via least squares linear regression.[Baseline visit and 3 months];Changes in heart rate during exercise echocardiography from baseline in patients taking empagliflozin compared with placebo.[Baseline visit and 3 months];Changes in blood pressure during exercise echocardiography from baseline in patients taking empagliflozin compared with placebo.[Baseline visit and 3 months]