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Prediabetes and Type 2 Diabetes in Aging

Effects of Prediabetes and Type 2 Diabetes on Cognitive Status, Physical Function, and Fatigue in Geriatric Individuals: A Case-Control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06953609
Enrollment
94
Registered
2025-05-01
Start date
2025-04-15
Completion date
2025-08-15
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function, Dual Task, Fatigue, Prediabetes, Type 2 Diabetes Mellitus (T2DM)

Keywords

type 2 diabetes mellitus, cognitive function, dual task, fatigue, prediabetes

Brief 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. 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.

Interventions

None listed

Sponsors

Uşak University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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,

Exclusion criteria

* 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, * 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

Design outcomes

Primary

MeasureTime frameDescription
Cognitive status assessmentAt the time of enrollmentThe 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.

Secondary

MeasureTime frameDescription
Reaction evaluationAt the time of enrollmentThe 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.
Assessment of Blood glucoseAt the time of the enrollmentBlood glucose (mg/dL) - To explore the relationship between glycemic status and fatigue.
Assessment of Cortisol (µg/dL)At the enrollmentCortisol (µg/dL) - Morning cortisol levels will be assessed as an indicator of adrenal function and fatigue.
Dual task performance assessmentAt the time of enrollmentTo 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
Physical Function AssessmentAt the time of enrollmentA 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.
Assessing sense of direction.At the time of enrollmentSanta 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.
Assessment of Hemoglobin levelAt the time of enrollmentHemoglobin level (g/dL) - Blood samples will be collected to measure the participants' hemoglobin concentration to evaluate fatigue-related anemia.
Assessment of Serum ferritinAt the time of enrollmentSerum ferritin (ng/mL) - To assess iron stores which may influence fatigue levels.
Assessment of Thyroid stimulating hormone (TSH)At the time of enrollmentThyroid stimulating hormone (TSH) (µIU/mL) - To evaluate thyroid-related causes of fatigue.
Assessment of C-reactive protein (CRP)At the time of enrollmentC-reactive protein (CRP) (mg/L) - As a marker of systemic inflammation related to fatigue.
Self-report assessment of fatigueAt the time of enrollmentFatigue 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026