Ignite Creation Date:
2024-05-06 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05164523
Status:
COMPLETED
Last Update Posted:
2023-09-05
First Post:
2021-10-17
Brief Title:
The Effect of SGLT2 Inhibitors on Heart Rate Variability and BDNF Levels in Patients With Type 2 Diabetes
Sponsor:
Goztepe Training and Research Hospital
Organization:
Goztepe Training and Research Hospital
Study Overview
Official Title:
The Effect of SGLT2 Inhibitors on Heart Rate Variability Sympathetic and Parasympathetic Activity and a Neuroinflammatory Biomarker Brain-Derived Neurotrophic Factor Levels in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None