Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05341388
Status:
TERMINATED
Last Update Posted:
2022-04-22
First Post:
2021-10-17
Brief Title:
The Effect of SGLT2 Inhibitors on Cognitive Functions 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 Cognitive Functions and a Neuroinflammatory Biomarker Brain-Derived Neurotrophic Factor Levels in Patients With Type 2 Diabetes
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not enough participants due to the pandemia
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cognitive impairment is a common complication in diabetes for various reasons Although glycemic control improves cognitive impairment different antidiabetic medications effects on cognitive functions are still being investigated Brain-derived neurotrophic factor BDNF is a neuroinflammatory marker and a member of the neurotrophin family with growth factor properties BDNF levels have been shown to decrease in mild cognitive dysfunction or in late-onset Alzheimers disease Our aim is to examine the effect of SGLT2 inhibitor use on cognitive functions and BDNF levels
Detailed Description:
Type 2 diabetes is a complex metabolic disorder that can cause serious damage to various organs Impairment in cognitive functions is one of the common complications in patients with diabetes Impairment in cognitive functions and significant dementia were found to be approximately 15 times more common in individuals with diabetes than individuals without diabetes In particular inadequate glycemic control the frequency of hypoglycemia vascular diseases insulin resistance inflammatory cytokines and oxidative stress stand out as possible causes Brain-derived neurotrophic factor BDNF is a member of the neurotrophin family with growth factor properties BDNF plays a critical role in cell differentiation migration and survivable synaptic plasticity of neurons BDNF also has an important role in learning and memory processes through synapses in the hippocampus BDNF levels have been shown to decrease in mild cognitive dysfunction or in late-onset Alzheimers disease In animal experiments it has been observed that BDNF values increase with the use of metformin in Parkinsons disease Similar results were obtained with vildagliptin alogliptin rosiglitazone and exendin-4 in animal experiments
The effects of drugs used in the treatment of diabetes on protecting or improving cognitive functions have been studied for a long time Most of these studies are at the preclinical level In previous studies with Glucagon-Like Peptide 1 GLP-1 agonists and dipeptidyl peptidase 4 DPP-4 inhibitors there are data that both glycemia and incretins improve cognitive functions with their effects on brain structure Similar positive results are seen for thiazolidinediones While hyperglycemia control leads to positive results in insulin and sulfonylurea group drugs the frequency of hypoglycemia can have a negative effect There is not enough data on SGLT2 inhibitors
Studies with SGLT2 inhibitors have shown a decrease in HbA1c values weight loss and a decrease in both systolic and diastolic blood pressure Encouraging results have been obtained with SGLT2 inhibitors in both cardiac and renal outcomes with heart failure in the foreground As a result of these data they are recommended as drugs that should be used in the foreground following metformin especially in diabetic patients with cardiac and renal diseases Animal studies with empagliflozin and canagliflozin show that both agents reduce cognitive impairment
Our aim is to examine the effect of SGLT2 inhibitor use on cognitive functions and BDNF one of the neuroinflammatory markers
The effects of drugs used in the treatment of diabetes on protecting or improving cognitive functions have been studied for a long time Most of these studies are at the preclinical level In previous studies with Glucagon-Like Peptide 1 GLP-1 agonists and dipeptidyl peptidase 4 DPP-4 inhibitors there are data that both glycemia and incretins improve cognitive functions with their effects on brain structure Similar positive results are seen for thiazolidinediones While hyperglycemia control leads to positive results in insulin and sulfonylurea group drugs the frequency of hypoglycemia can have a negative effect There is not enough data on SGLT2 inhibitors
Studies with SGLT2 inhibitors have shown a decrease in HbA1c values weight loss and a decrease in both systolic and diastolic blood pressure Encouraging results have been obtained with SGLT2 inhibitors in both cardiac and renal outcomes with heart failure in the foreground As a result of these data they are recommended as drugs that should be used in the foreground following metformin especially in diabetic patients with cardiac and renal diseases Animal studies with empagliflozin and canagliflozin show that both agents reduce cognitive impairment
Our aim is to examine the effect of SGLT2 inhibitor use on cognitive functions and BDNF one of the neuroinflammatory markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None