Type2 DiabetesNCT05341388
The Effect of SGLT2 Inhibitors on Cognitive Functions and BDNF Levels in Patients With Type 2 Diabetes
An observational study of Type2 Diabetes and Cognitive Impairment, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Type2 Diabetes, Cognitive Impairment
- What is being tested?
- MOCA cognitive evaluation test, BDNF levels and SF-36 test
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who refer to a diabetes outpatients clinics to an university hospital
Who may be able to join
- giving consent
- being 60 years old or older
- HbA1c concentrations between 6.5% and 8%
- using metformin as a single agent for at least 3 months
- diabetes age <10 years
Who cannot join
- having uncontrolled hypothyroidism, hyperthyroidism, or other diseases that may affect cognitive functions
- ketoacidosis or coma
- cerebrovascular disease or psychiatric disorder
- mental retardation, psychosis, dementia, brain trauma, epilepsy and other cerebral diseases
- alcohol or other substance abuse
- hearing loss
Show all 11Show fewer
- Presence of diseases that will affect cognitive function such as chronic inflammatory diseases and respiratory system diseases
- chronic kidney failure (GFR <45)
- sleep apnea syndrome
- malignancy
- using a sulfonylurea or glinide
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Goztepe Research and Training Hospital
Istanbul
About this study
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
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 Alzheimer's disease. Our aim is to examine the effect of SGLT2 inhibitor use on cognitive functions and BDNF levels.
Read the 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 1.5 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 Alzheimer's disease. In animal experiments, it has been observed that BDNF values increase with the use of metformin in Parkinson's 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.
- Conditions
- Type2 Diabetes, Cognitive Impairment
- Being tested
- MOCA cognitive evaluation test, BDNF levels, SF-36 test, Geriatric depression test
- Keywords
- type 2 diabetes, cognitive impairment, BDNF, SGLT2 inhibitors
- Medical subject headings
- Cognitive Dysfunction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOCA cognitive evaluation testDiagnostic test
Before starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial.
BDNF levelsDiagnostic test
Before starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial.
SF-36 testOther
Before starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial.
Geriatric depression testDiagnostic test
Before starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes-SGLT2 inh | patients with type 2 diabetes who were recently prescribed an SGLT2 inhibitor Receives: Diagnostic Test: MOCA cognitive evaluation test; Diagnostic Test: BDNF levels; Other: SF-36 test; Diagnostic Test: Geriatric depression test | |
| Patients with type 2 diabetes-control | patients with type 2 diabetes who were recently prescribed a pre-defined antidiabetic medication other than SGLT2 inhibitors Receives: Diagnostic Test: MOCA cognitive evaluation test; Diagnostic Test: BDNF levels; Other: SF-36 test; Diagnostic Test: Geriatric depression test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functions
We will observe the effects of SGLT2 inhibitors and other oral antidiabetic agents on cognitive functions in type 2 diabetic patients using Montreal Cognitive Assessment (MOCA) test
Measured: Six months
BDNF concentrations
We will observe the effects of SGLT2 inhibitors and other oral antidiabetic agents on BDNF levels in type 2 diabetic patients. We will also assess whether there is an association between cognitive functions and BDNF concentrations in these prespecified groups of patients.
Measured: Six months
Secondary outcomes (1)
36 item Short Form Survey (SF-36)
We will observe the effects of SGLT2 inhibitors and other oral antidiabetic agents on quality of life of life in type 2 diabetic patients using SF-36 survey.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Mar 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Why it stopped: not enough participants due to the pandemia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse N Erbakan, Goztepe Training and Research Hospital
- Investigators
- Ayse N Erbakan, MD, Principal investigator, Istanbul Medeniyet University Goztepe Research and TRaining HospitalMehmet Sargın, Prof, Study chair, Istanbul Medeniyet UniversityNazmiye Özbilgin, Prof, Study chair, University of Health Sciences Siyami Ersek TCS Training and Research HospitalAytekin Oğuz, Prof, Study chair, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341388
- Sponsor's protocol ID
- Cognitive-BDNF
- Status last verified
- Apr 2022
- First submitted
- 17 Oct 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05341388
- Acronym / sponsor ID
- Cognitive-BDNF
- Conditions
- Type2 Diabetes, Cognitive Impairment
- Keywords
- type 2 diabetes, cognitive impairment, BDNF, SGLT2 inhibitors
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not enough participants due to the pandemia
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Goztepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Alzheimer's 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 1.5 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 Alzheimer's disease. In animal experiments, it has been observed that BDNF values increase with the use of metformin in Parkinson's 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes-SGLT2 inh | – | Diagnostic Test: MOCA cognitive evaluation test, Diagnostic Test: BDNF levels, Other: SF-36 test, Diagnostic Test: Geriatric depression testpatients with type 2 diabetes who were recently prescribed an SGLT2 inhibitor |
| Patients with type 2 diabetes-control | – | Diagnostic Test: MOCA cognitive evaluation test, Diagnostic Test: BDNF levels, Other: SF-36 test, Diagnostic Test: Geriatric depression testpatients with type 2 diabetes who were recently prescribed a pre-defined antidiabetic medication other than SGLT2 inhibitors |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who refer to a diabetes outpatients clinics to an university hospital
Key inclusion criteria (5 listed)
- giving consent
- being 60 years old or older
- HbA1c concentrations between 6.5% and 8%
- using metformin as a single agent for at least 3 months
- diabetes age <10 years
Key exclusion criteria (11 listed)
- having uncontrolled hypothyroidism, hyperthyroidism, or other diseases that may affect cognitive functions
- ketoacidosis or coma
- cerebrovascular disease or psychiatric disorder
- mental retardation, psychosis, dementia, brain trauma, epilepsy and other cerebral diseases
- alcohol or other substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOCA cognitive evaluation testBefore starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial. | Diagnostic test | Patients with type 2 diabetes-SGLT2 inh, Patients with type 2 diabetes-control |
| BDNF levelsBefore starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial. | Diagnostic test | Patients with type 2 diabetes-SGLT2 inh, Patients with type 2 diabetes-control |
| SF-36 testBefore starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial. | Other | Patients with type 2 diabetes-SGLT2 inh, Patients with type 2 diabetes-control |
| Geriatric depression testBefore starting their newly prescribed medication, we will apply MOCA and repeat it at the end of the trial. | Diagnostic test | Patients with type 2 diabetes-SGLT2 inh, Patients with type 2 diabetes-control |
Primary outcome
Cognitive functions
Time frame: Six months
We will observe the effects of SGLT2 inhibitors and other oral antidiabetic agents on cognitive functions in type 2 diabetic patients using Montreal Cognitive Assessment (MOCA) test
BDNF concentrations
Time frame: Six months
We will observe the effects of SGLT2 inhibitors and other oral antidiabetic agents on BDNF levels in type 2 diabetic patients. We will also assess whether there is an association between cognitive functions and BDNF concentrations in these prespecified groups of patients.
1 secondary outcome
36 item Short Form Survey (SF-36)
Time frame: Six months
Results and safety
The study was stopped early (reason given: not enough participants due to the pandemia). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse N Erbakan, MD principal investigator
Istanbul Medeniyet University Goztepe Research and TRaining Hospital
Mehmet Sargın, Prof study chair
Istanbul Medeniyet University
Nazmiye Özbilgin, Prof study chair
University of Health Sciences Siyami Ersek TCS Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes and Cognitive Impairment, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not enough participants due to the pandemia). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive functions (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.