Type 2 DiabetesNCT07390292
Assessment of Cognitive Function and Functional Performance in Patients With Type 2 Diabetes
An observational study of Type 2 Diabetes, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Diabetes is a chronic metabolic disease that is becoming a growing public health problem worldwide, affecting people's lives in many ways. It is characterized by impaired carbohydrate, lipid, and protein metabolism associated with insufficient insulin secretion and/or reduced sensitivity to the metabolic effects of… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2026to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be conducted at Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, including the Pulmonary Physiotherapy and Rehabilitation Education and Research Laboratory and the Cardiac Physiotherapy and Rehabilitation Education and Research Laboratory, using face-to-face interview methods with the participants.
Who may be able to join
- Being between 40 and 65 years of age
- Having an HbA1c level between 6.5 and 11
- Having been diagnosed with diabetes for at least 1 year
- Scoring 24 or higher on the Mini-Mental State Examination
- Being able to walk independently without assistance
- Having provided voluntary participation and signed written informed consent
Who cannot join
- Having a diagnosis of any neurological or psychiatric disorder (e.g., hemiplegia, Alzheimer's disease, Parkinson's disease)
- Having uncontrolled hypertension and/or uncontrolled cardiac arrhythmia
- Having vertigo or other vestibular system disorders
- Having major musculoskeletal disorders
- Having undergone percutaneous transluminal coronary angioplasty or having a cardiac pacemaker
- Being pregnant
- Being unable to read or write in Turkish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul
Ece Bulut, Master's student, +905368889609, 245323001@bvu.edu.tr
ECE BULUT, PT, Master's student
About this study
Official title: The Effect of Cognitive Functions on Functional Capacity, Balance, Fear of Falling and Quality of Life in Patients With Type 2 Diabetes
Diabetes is a chronic metabolic disease that is becoming a growing public health problem worldwide, affecting people's lives in many ways. It is characterized by impaired carbohydrate, lipid, and protein metabolism associated with insufficient insulin secretion and/or reduced sensitivity to the metabolic effects of insulin.Along with diabetes, many complications may develop in affected individuals. Cognitive impairments are now also considered an important and common complication of diabetes.The aim of this study is to investigate the effects of cognitive function levels on functional capacity, balance, fear of falling, and quality of life in individuals with type 2 diabetes.In this context, participants' cognitive function levels will be assessed using the Mini-Mental State Examination and the Stroop Test. Functional capacity will be evaluated using the 6-Minute Walk Test. Balance performance will be assessed using the Biodex Balance System and the Four Square Step Test. Lower extremity muscle strength will be measured using a digital hand-held dynamometer and the 30-Second Sit-to-Stand Test. Fear of falling will be evaluated using the Falls Efficacy Scale-International (FES-I), the Functional Reach Test, and the Timed Up and Go (TUG) Test. Participants' quality of life will be assessed using the WHOQOL-BREF quality of life questionnaire.
Read the detailed description
The study will include 40 volunteer patients diagnosed with Type 2 Diabetes Mellitus and a control group consisting of 40 healthy individuals without any chronic disease, matched in terms of age and sex. The research will be conducted at the Cardiac and Pulmonary Physiotherapy and Physiotherapy and Rehabilitation Education and Research Laboratory of Bezmialem Vakıf University Eyüp Campus. This study is designed as a cross-sectional study based on the objective evaluation of the current condition without any intervention or treatment.
Written informed consent will be obtained from all participants prior to participation. Subsequently, the demographic and clinical data of the participants will be recorded. Cognitive functions will be assessed using the Mini-Mental State Examination (MMSE) and the Stroop Test. Body composition will be measured using the digital and portable Omron BF511 Body Composition Monitor. Lower extremity muscle strength will be evaluated using an electronic hand-held dynamometer, and in addition, the 30-Second Sit-to-Stand Test will be performed.
Balance performance will be assessed using the Biodex Balance System; within this system, the Postural Stability Test, Limits of Stability Test, and Sensory Organization Test will be performed. In addition, the Four Square Step Test will also be conducted as a measure to support the assessment of dynamic balance.
Fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I), the Functional Reach Test, and the Timed Up and Go (TUG) Test. Participants' quality of life levels will be determined using the WHOQOL-BREF Quality of Life Questionnaire. All obtained results will be compared between individuals with type 2 diabetes and the healthy control group; the relationships between cognitive function levels and functional capacity, balance, fear of falling, and quality of life will be examined using statistical analyses.
The implementation of all assessments takes approximately 40-45 minutes for each participant.
Statistical analysis of the data will be performed using SPSS v.20 software, and a significance level of p<0.05 will be accepted.
- Conditions
- Type 2 Diabetes
- Being tested
- No intervention (observational study)
- Keywords
- Type 2 Diabetes Mellitus, Cognitive Function, Balance, Functional Capacity
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
This is an observational study. No treatment was applied to the individuals. The study will evaluate the individuals' cognitive functions and functional capacities, balance, fear of falling, and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes Mellitus Group | Not described Receives: Other: No intervention (observational study) | |
| Healthy Control Group | Not described Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Stability
Postural stability will be assessed using the Biodex Balance System®. This assessment is performed to evaluate the individual's ability to maintain the center of body mass.
Deviations from the center of balance will be recorded during the test. Higher stability index scores indicate greater deviation from the center of balance and poorer postural stability.
Measured: Single assessment at baseline
Limits of Stability
This assessment will be conducted using the Biodex Balance System®. The test will be performed on a static platform. The purpose of the test is to evaluate the individual's ability to shift and control the center of body mass within the base of support.
Directional control (overall, forward, backward, left, right, forward/left, forward/right, backward/left, backward/right) will be assessed and expressed as a percentage (%).
Higher scores are associated with better postural control.
Measured: Single assessment at baseline
Sensory Integration of Balance
This assessment will be conducted using the Biodex Balance System®. The purpose of the test is to evaluate how different sensory inputs contribute to the maintenance of balance and how well balance can be preserved when one or more of these sensory inputs are removed.
The test will be performed under the following conditions: eyes open and eyes closed on a firm surface, and eyes open and eyes closed on a foam surface.
A sway index will be calculated for each condition.
Measured: Single assessment at baseline
Secondary outcomes (15)
Stroop Test
The Stroop Test is used to assess cognitive function, including processing speed, selective attention, cognitive flexibility, and the ability to inhibit automatic responses.The test consists of three parts, in which participants are required to perform color-word tasks. The completion time of the test will be recorded in seconds.
Measured: Single assessment at baseline
Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) will be used to assess general cognitive function. The test evaluates the domains of orientation, attention, memory, calculation, and language. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Single assessment at baseline
Four Square Step Test
It is used to assess dynamic balance during obstacle negotiation. The patient is instructed to step over four canes placed on the floor in a cross configuration, following a specified sequence.
The completion time of the test is recorded in seconds.
Measured: Single assessment at baseline
Assessment of Functional Capacity
Functional capacity will be assessed using the 6-minute walk test. This test involves participants walking along a 30-meter corridor at their own pace for six minutes, with the distance recorded in meters. At the end of six minutes, the participant is informed that the test is complete and the test is terminated. The expected average walking distance for healthy individuals ranges from 400 to 700 meters.
Measured: Single assessment at baseline
30 Second Sit to Stand Test
Lower extremity muscle strength will be assessed using the 30-second chair stand test.
During the test, participants will be instructed to stand up from a chair for 30 seconds with their arms crossed over their chest and their feet flat on the floor.
The number of completed stands will be recorded to evaluate functional lower extremity muscle strength.
Measured: Single assessment at baseline
Quadriceps Femoris Muscle Strength
Quadriceps femoris muscle strength will be assessed using an electronic hand-held dynamometer.Participants will be instructed to sit with the knee in full extension, while the physiotherapist applies maximal resistance at the ankle to evaluate the isometric strength of the quadriceps femoris muscle.The muscle strength value will be recorded in kilograms (kg).
Measured: Single assessment at baseline
Falls Efficacy Scale-International (FES-I)
To assess fear of falling, fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I).The scale consists of 16 items that assess individuals' levels of concern related to falling during daily activities.Each item is scored from 1 (not at all concerned) to 4 (very concerned).
The total score will be recorded.
Measured: Single assessment at baseline
Functional Reach Test
The Functional Reach Test is performed to assess fall risk. During the test, participants are instructed to stand, raise the arm to approximately 90 degrees, and reach forward as far as possible without stepping or losing balance.The distance between the starting position of the hand and the furthest point reached is recorded in centimeters (cm).Values of 15 cm or less indicate an increased risk of falling.
Measured: Single assessment at baseline
Timed Up and Go (TUG) Test
The Timed Up and Go (TUG) Test is performed to assess fall risk. The test requires a chair and a stopwatch. A 3-meter distance is marked in front of the chair, and participants are instructed to stand up from the chair on the command "go," walk this distance at a normal pace, and sit down again.
The completion time of the test is recorded in seconds. Longer completion times are associated with an increased risk of falling.
Measured: Single assessment at baseline
Assessment of Quality of Life
Quality of life will be assessed using the WHOQOL-BREF questionnaire. The WHOQOL-BREF consists of four domains: physical health (7 items), psychological well-being (6 items), social relationships (3 items), and environmental health (8 items). All items are rated on a 5-point Likert scale and scored from 1 to 5.
Measured: Single assessment at baseline
Body Mass İndex
Body mass index will be taken into consideration during evaluation. Body height (m) will be measured using standardized procedures, and body weight (kg) will be measured using the Omron BF511 Body Composition Monitor. Body Mass Index (BMI) will be calculated by dividing body weight (kg) by the square of height in meters (kg/m²).
Measured: Single assessment at baseline
Body Fat Mass (kg)
Body fat mass (kg) will be measured using the Omron BF511 Body Composition Monitor according to the standard protocol of the device.
Measured: Single assessment at baseline
Skeletal Muscle Mass (kg)
Skeletal muscle mass (kg) will be measured using the Omron BF511 Body Composition Monitor according to the standard protocol of the device.
Measured: Single assessment at baseline
Resting Metabolic Rate
Resting metabolic rate (kcal) will be assessed using the Omron BF511 Body Composition Monitor.
Measured: Single assessment at baseline
Visceral Fat Level
Visceral fat level will be assessed using the Omron BF511 Body Composition Monitor according to the manufacturer's instructions.
Measured: Single assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390292
- Sponsor's protocol ID
- 2025/251
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Functions on Functional Capacity, Balance, Fear of Falling and Quality of Life in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07390292
- Acronym / sponsor ID
- 2025/251
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes Mellitus, Cognitive Function, Balance, Functional Capacity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 5 Feb 2026 (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.
Diabetes is a chronic metabolic disease that is becoming a growing public health problem worldwide, affecting people's lives in many ways. It is characterized by impaired carbohydrate, lipid, and protein metabolism associated with insufficient insulin secretion and/or reduced sensitivity to the metabolic effects of insulin.Along with diabetes, many complications may develop in affected individuals. Cognitive impairments are now also considered an important and common complication of diabetes.The aim of this study is to investigate the effects of cognitive function levels on functional capacity, balance, fear of falling, and quality of life in individuals with type 2 diabetes.In this context, participants' cognitive function levels will be assessed using the Mini-Mental State Examination and the Stroop Test. Functional capacity will be evaluated using the 6-Minute Walk Test. Balance performance will be assessed using the Biodex Balance System and the Four Square Step Test. Lower extremity muscle strength will be measured using a digital hand-held dynamometer and the 30-Second Sit-to-Stand Test. Fear of falling will be evaluated using the Falls Efficacy Scale-International (FES-I), the Functional Reach Test, and the Timed Up and Go (TUG) Test. Participants' quality of life will be assessed using the WHOQOL-BREF quality of life questionnaire.
Detailed description
The study will include 40 volunteer patients diagnosed with Type 2 Diabetes Mellitus and a control group consisting of 40 healthy individuals without any chronic disease, matched in terms of age and sex. The research will be conducted at the Cardiac and Pulmonary Physiotherapy and Physiotherapy and Rehabilitation Education and Research Laboratory of Bezmialem Vakıf University Eyüp Campus. This study is designed as a cross-sectional study based on the objective evaluation of the current condition without any intervention or treatment.
Written informed consent will be obtained from all participants prior to participation. Subsequently, the demographic and clinical data of the participants will be recorded. Cognitive functions will be assessed using the Mini-Mental State Examination (MMSE) and the Stroop Test. Body composition will be measured using the digital and portable Omron BF511 Body Composition Monitor. Lower extremity muscle strength will be evaluated using an electronic hand-held dynamometer, and in addition, the 30-Second Sit-to-Stand Test will be performed.
Balance performance will be assessed using the Biodex Balance System; within this system, the Postural Stability Test, Limits of Stability Test, and Sensory Organization Test will be performed. In addition, the Four Square Step Test will also be conducted as a measure to support the assessment of dynamic balance.
Fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I), the Functional Reach Test, and the Timed Up and Go (TUG) Test. Participants' quality of life levels will be determined using the WHOQOL-BREF Quality of Life Questionnaire. All obtained results will be compared between individuals with type 2 diabetes and the healthy control group; the relationships between cognitive function levels and functional capacity, balance, fear of falling, and quality of life will be examined using statistical analyses.
The implementation of all assessments takes approximately 40-45 minutes for each participant.
Statistical analysis of the data will be performed using SPSS v.20 software, and a significance level of p<0.05 will be accepted.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Mellitus Group | – | Other: No intervention (observational study) |
| Healthy Control Group | – | Other: No intervention (observational study) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted at Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, including the Pulmonary Physiotherapy and Rehabilitation Education and Research Laboratory and the Cardiac Physiotherapy and Rehabilitation Education and Research Laboratory, using face-to-face interview methods with the participants.
Key inclusion criteria (6 listed)
- Being between 40 and 65 years of age
- Having an HbA1c level between 6.5 and 11
- Having been diagnosed with diabetes for at least 1 year
- Scoring 24 or higher on the Mini-Mental State Examination
- Being able to walk independently without assistance
Key exclusion criteria (7 listed)
- Having a diagnosis of any neurological or psychiatric disorder (e.g., hemiplegia, Alzheimer's disease, Parkinson's disease)
- Having uncontrolled hypertension and/or uncontrolled cardiac arrhythmia
- Having vertigo or other vestibular system disorders
- Having major musculoskeletal disorders
- Having undergone percutaneous transluminal coronary angioplasty or having a cardiac pacemaker
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 |
|---|---|---|
| No intervention (observational study)This is an observational study. No treatment was applied to the individuals. The study will evaluate the individuals' cognitive functions and functional capacities, balance, fear of falling, and quality of life. | Other | Healthy Control Group, Type 2 Diabetes Mellitus Group |
Primary outcome
Postural Stability
Time frame: Single assessment at baseline
Postural stability will be assessed using the Biodex Balance System®. This assessment is performed to evaluate the individual's ability to maintain the center of body mass. Deviations from the center of balance will be recorded during the test. Higher stability index scores indicate greater deviation from the center of balance and poorer postural stability.
Limits of Stability
Time frame: Single assessment at baseline
This assessment will be conducted using the Biodex Balance System®. The test will be performed on a static platform. The purpose of the test is to evaluate the individual's ability to shift and control the center of body mass within the base of support. Directional control (overall, forward, backward, left, right, forward/left, forward/right, backward/left, backward/right) will be assessed and expressed as a percentage (%). Higher scores are associated with better postural control.
Sensory Integration of Balance
Time frame: Single assessment at baseline
This assessment will be conducted using the Biodex Balance System®. The purpose of the test is to evaluate how different sensory inputs contribute to the maintenance of balance and how well balance can be preserved when one or more of these sensory inputs are removed. The test will be performed under the following conditions: eyes open and eyes closed on a firm surface, and eyes open and eyes closed on a foam surface. A sway index will be calculated for each condition.
15 secondary outcomes
Stroop Test
Time frame: Single assessment at baseline
Mini-Mental State Examination (MMSE)
Time frame: Single assessment at baseline
Four Square Step Test
Time frame: Single assessment at baseline
Assessment of Functional Capacity
Time frame: Single assessment at baseline
30 Second Sit to Stand Test
Time frame: Single assessment at baseline
Quadriceps Femoris Muscle Strength
Time frame: Single assessment at baseline
Falls Efficacy Scale-International (FES-I)
Time frame: Single assessment at baseline
Functional Reach Test
Time frame: Single assessment at baseline
Timed Up and Go (TUG) Test
Time frame: Single assessment at baseline
Assessment of Quality of Life
Time frame: Single assessment at baseline
Body Mass İndex
Time frame: Single assessment at baseline
Body Fat Mass (kg)
Time frame: Single assessment at baseline
Skeletal Muscle Mass (kg)
Time frame: Single assessment at baseline
Resting Metabolic Rate
Time frame: Single assessment at baseline
Visceral Fat Level
Time frame: Single assessment at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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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.
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 Type 2 Diabetes, 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 5 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Stability (time frame: Single assessment at baseline). The study lists 3 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 5 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.