Diabetes Mellitus, Type 2NCT05725889
Detection of Visual-Auditory Reaction Rates in Individuals With Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2 and Cognitive Dysfunction, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Background: The primary purpose of our study was to understand the damage in the peripheral nerves of patients with diabetes and to determine the change in patients' reaction rates and perceptions by the age groups, duration of diabetes, fasting plasma glucose and HbA1c values, and compare these with those of the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cognitive Dysfunction, Nerve Damage
- What is being tested?
- recation time test
- Type of treatment
- Medical device
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2021to 14 Sep 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of healthy individuals aged between 18-64 years, diagnosed with type 2 diabetes, and resided in Ankara. The sample comprised 128 volunteers, 64 of whom were patients and 64 were controls.
Who may be able to join
- Right-handed individuals
- Must be between 18-65 ages
- Must be Type 2 diabetics at least 6 months (for patient group)
Who cannot join
- use of alcohol-drug or similar substances,
- the use of any medication that may affect neurological functions,
- having color blindness,
- retinopathy,
- neurological disease,
- cancer,
Show all 11Show fewer
- depression,
- a recent history of surgery,
- rheumatoid arthritis,
- osteoarthritis,
- and advanced osteoarthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Background: The primary purpose of our study was to understand the damage in the peripheral nerves of patients with diabetes and to determine the change in patients' reaction rates and perceptions by the age groups, duration of diabetes, fasting plasma glucose and HbA1c values, and compare these with those of the healthy individuals.
Methods: This study was carried out at the Baskent University Hospital Endocrinology and Metabolic Diseases Outpatient Clinic. A total of 64 patients diagnosed with type 2 diabetes and 64 healthy controls were included in the study. Finger tapping, visual, and auditory reaction time tests were performed on the subjects, respectively. The subjects' fasting plasma glucose and HbA1c levels, and the duration of their diabetes were recorded. Analyses were performed using the SPSS version 25. Differences were considered statistically significant when the p-value is <0.05.
- Being tested
- recation time test
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recation time testDevice
visual-finger tapping and auditory reaction time tests
| Study group | Role | What they receive |
|---|---|---|
| DIABETES | Visual, finger tapping and auditory tests were performed regularly. The subjects' fasting plasma glucose and HbA1c levels, and the duration of their diabetes were recorded. Receives: Device: recation time test | |
| CONTROL | Visual, finger tapping and auditory tests were performed regularly. The subjects' fasting plasma glucose and HbA1c levels were recorded. Receives: Device: recation time test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger tap, visual and auditory reaction test data within 10 seconds
Reaction times
Measured: April-September 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start15 Jul 2021
- Primary completion15 Aug 2021
- Study completion14 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Cross-sectional
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, melisa bilaloğlu, Baskent University
- Investigators
- melisa bilaloğlu, res asst, Study chair, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725889
- Sponsor's protocol ID
- 193.140.162.4
- Status last verified
- Feb 2023
- First submitted
- 29 Nov 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Visual-Auditory Reaction Rates in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05725889
- Acronym / sponsor ID
- 193.140.162.4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 13 Feb 2023 (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.
Background: The primary purpose of our study was to understand the damage in the peripheral nerves of patients with diabetes and to determine the change in patients' reaction rates and perceptions by the age groups, duration of diabetes, fasting plasma glucose and HbA1c values, and compare these with those of the healthy individuals.
Methods: This study was carried out at the Baskent University Hospital Endocrinology and Metabolic Diseases Outpatient Clinic. A total of 64 patients diagnosed with type 2 diabetes and 64 healthy controls were included in the study. Finger tapping, visual, and auditory reaction time tests were performed on the subjects, respectively. The subjects' fasting plasma glucose and HbA1c levels, and the duration of their diabetes were recorded. Analyses were performed using the SPSS version 25. Differences were considered statistically significant when the p-value is <0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIABETES | – | Device: recation time testVisual, finger tapping and auditory tests were performed regularly. The subjects' fasting plasma glucose and HbA1c levels, and the duration of their diabetes were recorded. |
| CONTROL | – | Device: recation time testVisual, finger tapping and auditory tests were performed regularly. The subjects' fasting plasma glucose and HbA1c levels were recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of healthy individuals aged between 18-64 years, diagnosed with type 2 diabetes, and resided in Ankara. The sample comprised 128 volunteers, 64 of whom were patients and 64 were controls.
Key inclusion criteria (3 listed)
- Right-handed individuals
- Must be between 18-65 ages
- Must be Type 2 diabetics at least 6 months (for patient group)
Key exclusion criteria (11 listed)
- use of alcohol-drug or similar substances,
- the use of any medication that may affect neurological functions,
- having color blindness,
- retinopathy,
- neurological disease,
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 |
|---|---|---|
| recation time testvisual-finger tapping and auditory reaction time tests | Device | CONTROL, DIABETES |
Primary outcome
Finger tap, visual and auditory reaction test data within 10 seconds
Time frame: April-September 2021
Reaction times
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 13 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
melisa bilaloğlu, res asst study chair
Baskent University
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 Mellitus, Type 2 and Cognitive Dysfunction, run by Baskent 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 3 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: finished, as of the sponsor's last update on 13 Feb 2023. 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?
Finger tap, visual and auditory reaction test data within 10 seconds (time frame: April-September 2021). 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 13 Feb 2023.