The Effect of SGLT2 Inhibitors on Heart Rate Variability and BDNF Levels in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes; Heart Rate Variability
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Cardiac autonomic neuropathy (CAN) in diabetic patients is an indicator of autonomic nervous
      system dysfunction and is an important marker for cardiovascular events. Very promising
      results have been obtained with SGLT2 inhibitors in both cardiac and renal outcomes. The aim
      is to examine the effects of SGLT2 inhibitor use on cardiac autonomic neuropathy, heart rate
      variability, sympathetic and parasympathetic nervous system parameters, and their
      relationship with BDNF levels, one of the neuroinflammatory markers.
    

Detailed description: 
      Cardiac autonomic neuropathy (CAN) in diabetic patients is an indicator of autonomic nervous
      system dysfunction and is an important marker for cardiovascular events. Five-year mortality
      rates of diabetic patients with CAN are significantly higher than those without. Although
      there are various methods, primarily scintigraphic and pharmacological tests, to evaluate
      CAN, the practical use of these methods remains limited. In recent years, heart rate recovery
      (HRR) and heart rate variability (HRV) have been increasingly used as simple, inexpensive,
      and non-invasive methods to evaluate the status of heart sympathetic and vagus nerve
      functions. Values obtained as a result of 24-hour rhythm Holter provide the measurement of
      sympathetic and parasympathetic activity. While a significant relationship was observed
      between blood glucose levels and HRV in previous studies, no relationship was found between
      HbA1c levels and HRV.

      Brain-derived neurotrophic factor (BDNF) is a member of the neurotrophin family with growth
      factor properties. Studies with SGLT2 inhibitors have shown a decrease in HbA1c values,
      weight loss, and a decrease in both systolic and diastolic blood pressure. Very promising
      results have been obtained with SGLT2 inhibitors in both cardiac and renal outcomes. As a
      result of these data, these medications are recommended as drugs that should be used in the
      foreground following metformin, especially in diabetic patients with cardiac and renal
      diseases. In the study of Shimuz et al. in which the effects of empagliflozin and placebo on
      heart rate variability were compared in patients with acute myocardial infarction, HRV
      improved significantly with the use of empagliflozin in the early period. A study examining
      the effects of empagliflozin use on HRV in patients with type 2 diabetes is still ongoing.
      Apart from these 2 studies, no study was found in the literature.

      The aim of this study is to examine the effects of SGLT2 inhibitor use on cardiac autonomic
      neuropathy, heart rate variability, sympathetic and parasympathetic nervous system
      parameters, and their relationship with BDNF levels, one of the neuroinflammatory markers.
    

Intervention name(s): 24-hour rhythm Holter; 36 item Short Form Survey (SF-36)
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Before starting their newly prescribed medication, the investigators will apply 24-hour rhythm Holter and repeat it at the end of the trial.; Before starting their newly prescribed medication, the investigators will apply SF-36 survey and repeat it at the end of the trial.
Other intervention name(s): SF-36
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients who refer to a diabetes outpatients clinics to an university hospital
      
Keywords: type 2 diabetes; SGLT2 inhibitors; heart rate variability; sympathic activity; parasympathetic activity