Type 2 Diabetes Mellitus (T2DM)NCT06953609
Prediabetes and Type 2 Diabetes in Aging
An observational study of Type 2 Diabetes Mellitus (T2DM) and Cognitive Function, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
This case-control study will evaluate the effects of geriatric individuals on cognitive status, physical function and fatigue. Our study aims to compare the effects of geriatric individuals with prediabetes and type 2 diabetes with healthy geriatric individuals on cognitive status, physical function and fatigue. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Cognitive Function, Dual Task
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 15 Aug 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be conducted in 4 different Endocrinology clinics in Uşak, Turkey. Approximately 80 patients and healthy volunteers who meet the inclusion criteria for the study will be included in the study.
Who may be able to join
- for people without diabetes (healthy), those with Hemoglobin A1c Levels (HbA1c) normal range between 4% and 5.6%,
- those with HbA1c level between 5.7% and 6.4%, those with prediabetes (Impaired Glucose Tolerance),
- those with 6.5% -7.5% level and
- those with HbA1c level above 7.5
- criteria are being 60 years of age and older,
Who cannot join
- those who have major depression,
- uncontrolled thyroid disease,
- those with vitamin B12, folic acid deficiency and anemia,
- those with uncontrolled hypertension,
- those with nephropathy and retrophy,
- those with any neuropsychological disorder, a history of alcohol, substance or drug addiction,
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- those using any neurological or psychological medication (anticonvulsant drugs, antidepressants, anxiolytics, etc.),
- those with Alzheimer's and Parkinson's disease,
- those with cancer,
- those with lung disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uşak Education and Research Hospital
Uşak, Uşak, 64200
About this study
Official title: Effects of Prediabetes and Type 2 Diabetes on Cognitive Status, Physical Function, and Fatigue in Geriatric Individuals: A Case-Control Study
This case-control study will evaluate the effects of geriatric individuals on cognitive status, physical function and fatigue. Our study aims to compare the effects of geriatric individuals with prediabetes and type 2 diabetes with healthy geriatric individuals on cognitive status, physical function and fatigue. Accordingly, the hypotheses of the study are as follows:
Hypothesis 1: Prediabetes and Type 2 Diabetes Negatively Affect Cognitive Status in Geriatric Individuals.
Read more
Hypothesis 2: Physical Function Loss is More Pronounced in Individuals with Prediabetes and Type 2 Diabetes.
Hypothesis 3: Fatigue Level Will Increase in Geriatric Individuals with Prediabetes and Type 2 Diabetes.
Hypothesis 4: There Will Be a Correlation Between the Effects of Prediabetes and Type 2 Diabetes on Cognitive Status, Physical Function and Fatigue.
Hypothesis 5: Severity of Diabetes (Prediabetes vs. Type 2 Diabetes) Will Create Differences in Cognitive, Physical and Fatigue Status.
Prediabetic, diabetic and healthy volunteers constitute the universe of the study. There will be 4 different groups in the study. These groups are; those with normal range of Hemoglobin A1c Levels (HbA1c) between 4% and 5.6% for people without diabetes (Healthy), those with HbA1c level between 5.7% and 6.4%, those with prediabetes (Impaired Glucose Tolerance), those with 6.5% - 7.5% and those with HbA1c level above 7.5. Cognitive status, physical functions, dual task performance, motor motor and motor cognitive performances, fatigue, reaction reactions, directional skills of elderly individuals will be compared between these groups.
Read the detailed description
Type 2 Diabetes Mellitus develops due to insulin resistance and/or decreased insulin secretion and is particularly common in the elderly population. With the aging process, metabolic changes and increased insulin resistance increase the risk of diabetes. Long-term complications of diabetes can negatively affect the quality of life in geriatric individuals with effects such as cognitive impairment, loss of physical function and fatigue. In individuals with diabetes, hyperglycemia, microvascular complications and inflammation can increase the risk of cognitive decline. This can pave the way for dementia and Alzheimer's disease. Prediabetes is a condition in which blood sugar levels are higher than normal, but not high enough to diagnose diabetes, and this is an important risk factor for Type 2 Diabetes Mellitus. Even prediabetes has been associated with deterioration in cognitive functions. Loss of muscle mass (sarcopenia) and decreased physical endurance are frequently seen in geriatric individuals with diabetes. These individuals are likely to experience mobility problems and have an increased risk of falling. Chronic fatigue is another common complication of diabetes. Hyperglycemia can affect energy metabolism and cause fatigue. Fatigue can reduce physical activity levels and worsen general health status. Based on this, the study will include 4 groups: geriatric individuals with prediabetes and type 2 diabetes (controlled and uncontrolled) and healthy geriatric individuals. It will be compared whether there are any differences between these groups in terms of cognitive status, reaction times, sense of direction, dual task performance, physical function and fatigue.
- Keywords
- type 2 diabetes mellitus, cognitive function, dual task, fatigue, prediabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Fatigue, Prediabetic State
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 |
|---|---|---|
| Healthy | The normal range for Hemoglobin A1c Levels (HbA1c) for people without diabetes (Healthy) is those with an HbA1c level between 4% and 5.6%, | |
| A prediabetes (Impaired Glucose Tolerance) | those with a prediabetes (Impaired Glucose Tolerance) level between 5.7% and 6.4% | |
| Those with type 2 DM (controlled) | those with a HbA1c Levels of 6.5% - 7.5% | |
| Those with type 2 DM (uncontrolled) | those with an HbA1c level above 7.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive status assessment
The cognitive status of elderly individuals will be assessed with the Montreal Cognitive Assessment test. MoCA is a neuropsychological test developed to assess mild cognitive impairment (MCI) and early-stage dementia. It is evaluated out of 30 points and a score of 26 and above is considered normal. Validity and reliability in Turkish have been performed.
Measured: At the time of enrollment
Secondary outcomes (11)
Assessing sense of direction.
Santa Barbara Sense of Direction Scale (SBSOD): It is a self-report scale that assesses the ability of individuals to find their way. It assesses components such as wayfinding competence, internal mapping skills, and environmental cognition. Scale structure: It usually consists of 15 items and is assessed with a Likert-type score between 1-7. Subtests: It includes visual-spatial skills, short-term memory, attention, concentration, working memory, language, and orientation.
Measured: At the time of enrollment
Reaction evaluation
The Nelson Foot Reaction Test will be used to evaluate the reaction. Nelson Foot Reaction Test: It is a test that measures the reaction time to visual stimuli. In the foot reaction test, the ruler is placed between the fingers.
The operator holds the ruler from its tip and up. After giving the ready signal, he/she releases the ruler for a while. The subject tries to catch the ruler as soon as possible. The reaction time is calculated according to the distance at the point he/she caught and recorded.
Measured: At the time of enrollment
Assessment of Blood glucose
Blood glucose (mg/dL) - To explore the relationship between glycemic status and fatigue.
Measured: At the time of the enrollment
Assessment of Cortisol (µg/dL)
Cortisol (µg/dL) - Morning cortisol levels will be assessed as an indicator of adrenal function and fatigue.
Measured: At the enrollment
Dual task performance assessment
To assess dual task performance, both motor-motor and motor-cognitive tasks will be assessed.
Cognitive-Motor Task: Walking 3 meters while counting the days of the week backwards, assesses the interaction between walking and cognitive workload.
Motor-Motor Task: Walking 3 meters while carrying 4 water bottles, assesses postural control and motor coordination
Measured: At the time of enrollment
Physical Function Assessment
A distance of 3 meters is measured for the starting and returning points and this distance is taped. The patient is seated in a chair next to the starting line The procedure is explained to the patient The patient is asked to walk to the mark 3 meters away, turn around and sit back in the chair. The elapsed time is recorded with a stopwatch.
Measured: At the time of enrollment
Self-report assessment of fatigue
Fatigue is measured with both subjective scales. Self-report assessment of fatigue will be made with the fatigue severity scale.Fatigue Severity Scale is used to assess the level of fatigue of individuals in their daily life activities. It consists of 9 items and is scored between 1-7.
Measured: At the time of enrollment
Assessment of Hemoglobin level
Hemoglobin level (g/dL) - Blood samples will be collected to measure the participants' hemoglobin concentration to evaluate fatigue-related anemia.
Measured: At the time of enrollment
Assessment of Serum ferritin
Serum ferritin (ng/mL) - To assess iron stores which may influence fatigue levels.
Measured: At the time of enrollment
Assessment of Thyroid stimulating hormone (TSH)
Thyroid stimulating hormone (TSH) (µIU/mL) - To evaluate thyroid-related causes of fatigue.
Measured: At the time of enrollment
Assessment of C-reactive protein (CRP)
C-reactive protein (CRP) (mg/L) - As a marker of systemic inflammation related to fatigue.
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 Apr 2025
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser Gürsan, Uşak University
- Investigators
- Kevser Gursan, Dr., Principal investigator, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953609
- Sponsor's protocol ID
- 562-562-11
- Status last verified
- Sep 2025
- First submitted
- 19 Apr 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect participant confidentiality and comply with the confidentiality commitment approved by the ethics committee, no sharing of individual-level data is planned. In addition, the ethics committee decision that approved the study covers data use with limited access only. Therefore, it may not be possible to share IPD data publicly.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prediabetes and Type 2 Diabetes on Cognitive Status, Physical Function, and Fatigue in Geriatric Individuals: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06953609
- Acronym / sponsor ID
- 562-562-11
- Keywords
- type 2 diabetes mellitus, cognitive function, dual task, fatigue, prediabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 1 May 2025 (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.
This case-control study will evaluate the effects of geriatric individuals on cognitive status, physical function and fatigue. Our study aims to compare the effects of geriatric individuals with prediabetes and type 2 diabetes with healthy geriatric individuals on cognitive status, physical function and fatigue. Accordingly, the hypotheses of the study are as follows:
Hypothesis 1: Prediabetes and Type 2 Diabetes Negatively Affect Cognitive Status in Geriatric Individuals.
Hypothesis 2: Physical Function Loss is More Pronounced in Individuals with Prediabetes and Type 2 Diabetes.
Hypothesis 3: Fatigue Level Will Increase in Geriatric Individuals with Prediabetes and Type 2 Diabetes.
Hypothesis 4: There Will Be a Correlation Between the Effects of Prediabetes and Type 2 Diabetes on Cognitive Status, Physical Function and Fatigue.
Hypothesis 5: Severity of Diabetes (Prediabetes vs. Type 2 Diabetes) Will Create Differences in Cognitive, Physical and Fatigue Status.
Prediabetic, diabetic and healthy volunteers constitute the universe of the study. There will be 4 different groups in the study. These groups are; those with normal range of Hemoglobin A1c Levels (HbA1c) between 4% and 5.6% for people without diabetes (Healthy), those with HbA1c level between 5.7% and 6.4%, those with prediabetes (Impaired Glucose Tolerance), those with 6.5% - 7.5% and those with HbA1c level above 7.5. Cognitive status, physical functions, dual task performance, motor motor and motor cognitive performances, fatigue, reaction reactions, directional skills of elderly individuals will be compared between these groups.
Detailed description
Type 2 Diabetes Mellitus develops due to insulin resistance and/or decreased insulin secretion and is particularly common in the elderly population. With the aging process, metabolic changes and increased insulin resistance increase the risk of diabetes. Long-term complications of diabetes can negatively affect the quality of life in geriatric individuals with effects such as cognitive impairment, loss of physical function and fatigue. In individuals with diabetes, hyperglycemia, microvascular complications and inflammation can increase the risk of cognitive decline. This can pave the way for dementia and Alzheimer's disease. Prediabetes is a condition in which blood sugar levels are higher than normal, but not high enough to diagnose diabetes, and this is an important risk factor for Type 2 Diabetes Mellitus. Even prediabetes has been associated with deterioration in cognitive functions. Loss of muscle mass (sarcopenia) and decreased physical endurance are frequently seen in geriatric individuals with diabetes. These individuals are likely to experience mobility problems and have an increased risk of falling. Chronic fatigue is another common complication of diabetes. Hyperglycemia can affect energy metabolism and cause fatigue. Fatigue can reduce physical activity levels and worsen general health status. Based on this, the study will include 4 groups: geriatric individuals with prediabetes and type 2 diabetes (controlled and uncontrolled) and healthy geriatric individuals. It will be compared whether there are any differences between these groups in terms of cognitive status, reaction times, sense of direction, dual task performance, physical function and fatigue.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –The normal range for Hemoglobin A1c Levels (HbA1c) for people without diabetes (Healthy) is those with an HbA1c level between 4% and 5.6%, |
| A prediabetes (Impaired Glucose Tolerance) | – | –those with a prediabetes (Impaired Glucose Tolerance) level between 5.7% and 6.4% |
| Those with type 2 DM (controlled) | – | –those with a HbA1c Levels of 6.5% - 7.5% |
| Those with type 2 DM (uncontrolled) | – | –those with an HbA1c level above 7.5 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in 4 different Endocrinology clinics in Uşak, Turkey. Approximately 80 patients and healthy volunteers who meet the inclusion criteria for the study will be included in the study.
Key inclusion criteria (5 listed)
- for people without diabetes (healthy), those with Hemoglobin A1c Levels (HbA1c) normal range between 4% and 5.6%,
- those with HbA1c level between 5.7% and 6.4%, those with prediabetes (Impaired Glucose Tolerance),
- those with 6.5% -7.5% level and
- those with HbA1c level above 7.5
- criteria are being 60 years of age and older,
Key exclusion criteria (10 listed)
- those who have major depression,
- uncontrolled thyroid disease,
- those with vitamin B12, folic acid deficiency and anemia,
- those with uncontrolled hypertension,
- those with nephropathy and retrophy,
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 status assessment
Time frame: At the time of enrollment
The cognitive status of elderly individuals will be assessed with the Montreal Cognitive Assessment test. MoCA is a neuropsychological test developed to assess mild cognitive impairment (MCI) and early-stage dementia. It is evaluated out of 30 points and a score of 26 and above is considered normal. Validity and reliability in Turkish have been performed.
11 secondary outcomes
Assessing sense of direction.
Time frame: At the time of enrollment
Reaction evaluation
Time frame: At the time of enrollment
Assessment of Blood glucose
Time frame: At the time of the enrollment
Assessment of Cortisol (µg/dL)
Time frame: At the enrollment
Dual task performance assessment
Time frame: At the time of enrollment
Physical Function Assessment
Time frame: At the time of enrollment
Self-report assessment of fatigue
Time frame: At the time of enrollment
Assessment of Hemoglobin level
Time frame: At the time of enrollment
Assessment of Serum ferritin
Time frame: At the time of enrollment
Assessment of Thyroid stimulating hormone (TSH)
Time frame: At the time of enrollment
Assessment of C-reactive protein (CRP)
Time frame: At the time of enrollment
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 Sep 2025.
- Individual participant dataSharing planned: No. In order to protect participant confidentiality and comply with the confidentiality commitment approved by the ethics committee, no sharing of individual-level data is planned. In addition, the ethics committee decision that approved the study covers data use with limited access only. Therefore, it may not be possible to share IPD data publicly.
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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.
Kevser Gursan, Dr. principal investigator
Uşak 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 Type 2 Diabetes Mellitus (T2DM) and Cognitive Function, run by Uşak 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 5 inclusion and 10 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 Sep 2025. 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 status assessment (time frame: At the time of enrollment). 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 Sep 2025.