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.

Effects of Empagliflozin on Autonomic Nervous System Function and Cardiac Function in Patients with Type 2 Diabetes.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000887178

Enrollment

Registered

2019-06-26

Start date

2019-07-01

Completion date

2021-12-20

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The overall aims are to assess changes in cardiac function and sympathetic nervous system activity at rest and during exercise with empagliflozin in patients with type 2 diabetes without established heart disease. We hypothesised that: - 3 months treatment with empagliflozin will be associated with a measurable improvement in exercise capacity as reflected by peak oxygen consumption during maximal exercise (VO2peak) in addition to key physiological variables during exercise (heart rate reserve, blood pressure and ventilatory efficiency) in type 2 diabetes subjects without overt clinical heart failure. - Empagliflozin is associated with changes in sympathetic nervous system activity that may cause changes in cardiovascular function.

Interventions

3 months treatment with empagliflozin 25 mg oral tablet once daily in patients with type 2 diabetes. Adherence to the intervenstion will be monitored by indirect methods (self-reports, pill counts and patient diaries).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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

Outcome results