Diabetes Type 2NCT05654727
Cognitive Functions and BDNF in T2DM and Prediabetes Patients
An observational study of Diabetes Type 2 and PreDiabetes, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Clinical and epidemiological studies suggest links between cognitive impairments and Type 2 diabetes (T2DM). The underlying mechanisms and causality in diabetes-related cognitive impairment are largely unknown. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2, PreDiabetes, Cognitive Impairment
- How many people
- 230 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 1 Oct 2022
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetes, prediabetes and control patients who applied to the internal medicine outpatient clinic of Bezmialem Vakıf University and met the inclusion/exclusion conditions of the study
Who may be able to join
- age from 30 to 65 years
- having at least primary school education
Who cannot join
- severe psychiatric (e.g,major depressive disorder) or neurologic disorder (demyelinating diseases, stroke or brain tumor)
- using insulin (Insulin therapy was taken as an exclusion criterion to avoid the effect of hypoglycemia on cognition)
- vision and hearing problem
- Hypothyroidism, B12 and folic acid deficiency
- Advanced chronic renal failure (stage 4-5)
- uncontrolled hypertension
- patients with hypoglycemia-hyperglycemia attacks
- Alcohol, substance addiction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Impairment and BDNF in Patients With Diabetes and Prediabetes
Clinical and epidemiological studies suggest links between cognitive impairments and Type 2 diabetes (T2DM). The underlying mechanisms and causality in diabetes-related cognitive impairment are largely unknown. The aim of this study is to investigate cognitive impairment and the role of BDNF in prediabetes and diabetes patients.
Read the detailed description
Cognitive dysfunction is increasingly recognized as a common complication and comorbidity in both type 1 and type 2 diabetes (T2DM). Due to the increasing incidence of diabetes and the life expectancy of individuals with T2DM, it is important to determine the cognitive problems and related factors in these patients. Cognitive impairment can be observed in all age groups in individuals with diabetes, and its severity can range from mild cognitive impairment to dementia. Although there are few studies in the literature investigating cognitive impairment in prediabetes, it is not clear whether it is a risk factor.
The number of studies investigating biomarkers of potential importance for understanding changes in the brain of T2DM patients is increasing rapidly. The relationship of biomarkers associated with the main pathologies of dementia, including Alzheimer's disease (AD) and vascular disease, as well as various biomarkers associated with brain parenchymal damage, blood flow and metabolism, with the cognitive status of diabetic patients are investigated. It has been determined in animal experiments that Brain Induced Neurotrophic Factor (BDNF) may be among the molecular factors linking T2DM with dementia neuropathology. It has also been stated that high glucose levels are associated with cognitive impairment and total hippocampal volume reductions, and hippocampal changes can be used as an early marker of diabetes-related brain damage. Considering that the expression of BDNF in the brain is high in hippocampus neurons, it may be an early marker of cognitive impairment in diabetes.
This research is a cross-sectional observational study. The aim of this study is to investigate cognitive impairment and the role of BDNF in prediabetes and diabetes patients.
- Conditions
- Diabetes Type 2, PreDiabetes, Cognitive Impairment
- Keywords
- diabetes, BDNF, T2DM, prediabetes, cognition
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Cognitive Dysfunction, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes Mellitus | Not described | |
| Prediabetes | Not described | |
| Healthy Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Functions
MoCA total score and subscores were used to evalaute cognitive functions
Measured: baseline
BDNF
Serum BDNF were evaluated by Elisa
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Jul 2021
- Primary completion1 Jul 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654727
- Sponsor's protocol ID
- bsekerci1
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment and BDNF in Patients With Diabetes and Prediabetes
- ClinicalTrials.gov ID
- NCT05654727
- Acronym / sponsor ID
- bsekerci1
- Conditions
- Diabetes Type 2, PreDiabetes, Cognitive Impairment
- Keywords
- diabetes, BDNF, T2DM, prediabetes, cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 16 Dec 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.
Clinical and epidemiological studies suggest links between cognitive impairments and Type 2 diabetes (T2DM). The underlying mechanisms and causality in diabetes-related cognitive impairment are largely unknown. The aim of this study is to investigate cognitive impairment and the role of BDNF in prediabetes and diabetes patients.
Detailed description
Cognitive dysfunction is increasingly recognized as a common complication and comorbidity in both type 1 and type 2 diabetes (T2DM). Due to the increasing incidence of diabetes and the life expectancy of individuals with T2DM, it is important to determine the cognitive problems and related factors in these patients. Cognitive impairment can be observed in all age groups in individuals with diabetes, and its severity can range from mild cognitive impairment to dementia. Although there are few studies in the literature investigating cognitive impairment in prediabetes, it is not clear whether it is a risk factor.
The number of studies investigating biomarkers of potential importance for understanding changes in the brain of T2DM patients is increasing rapidly. The relationship of biomarkers associated with the main pathologies of dementia, including Alzheimer's disease (AD) and vascular disease, as well as various biomarkers associated with brain parenchymal damage, blood flow and metabolism, with the cognitive status of diabetic patients are investigated. It has been determined in animal experiments that Brain Induced Neurotrophic Factor (BDNF) may be among the molecular factors linking T2DM with dementia neuropathology. It has also been stated that high glucose levels are associated with cognitive impairment and total hippocampal volume reductions, and hippocampal changes can be used as an early marker of diabetes-related brain damage. Considering that the expression of BDNF in the brain is high in hippocampus neurons, it may be an early marker of cognitive impairment in diabetes.
This research is a cross-sectional observational study. The aim of this study is to investigate cognitive impairment and the role of BDNF in prediabetes and diabetes patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Mellitus | – | – |
| Prediabetes | – | – |
| Healthy Control | – | – |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetes, prediabetes and control patients who applied to the internal medicine outpatient clinic of Bezmialem Vakıf University and met the inclusion/exclusion conditions of the study
Key inclusion criteria (2 listed)
- age from 30 to 65 years
- having at least primary school education
Key exclusion criteria (8 listed)
- severe psychiatric (e.g,major depressive disorder) or neurologic disorder (demyelinating diseases, stroke or brain tumor)
- using insulin (Insulin therapy was taken as an exclusion criterion to avoid the effect of hypoglycemia on cognition)
- vision and hearing problem
- Hypothyroidism, B12 and folic acid deficiency
- Advanced chronic renal failure (stage 4-5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive Functions
Time frame: baseline
MoCA total score and subscores were used to evalaute cognitive functions
BDNF
Time frame: baseline
Serum BDNF were evaluated by Elisa
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Type 2 and PreDiabetes, run by Bezmialem Vakif University 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 19 Dec 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: baseline). 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 19 Dec 2022.