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NCT Number: NCT06953609

Prediabetes and Type 2 Diabetes in Aging

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Cognitive Function Diabetes Mellitus Diabetes Mellitus, Type 2 Dual Task Endocrine System Diseases Fatigue Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uşak Education and Research Hospital

Uşak, 64200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Assessing sense of direction.

    Time frame: At the time of enrollment

    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.

  2. Reaction evaluation

    Time frame: At the time of enrollment

    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.

  3. Assessment of Blood glucose

    Time frame: At the time of the enrollment

    Blood glucose (mg/dL) - To explore the relationship between glycemic status and fatigue.

  4. Assessment of Cortisol (µg/dL)

    Time frame: At the enrollment

    Cortisol (µg/dL) - Morning cortisol levels will be assessed as an indicator of adrenal function and fatigue.

  5. Dual task performance assessment

    Time frame: At the time of enrollment

    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

  6. Physical Function Assessment

    Time frame: At the time of enrollment

    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.

  7. Self-report assessment of fatigue

    Time frame: At the time of enrollment

    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.

  8. Assessment of Hemoglobin level

    Time frame: At the time of enrollment

    Hemoglobin level (g/dL) - Blood samples will be collected to measure the participants' hemoglobin concentration to evaluate fatigue-related anemia.

  9. Assessment of Serum ferritin

    Time frame: At the time of enrollment

    Serum ferritin (ng/mL) - To assess iron stores which may influence fatigue levels.

  10. Assessment of Thyroid stimulating hormone (TSH)

    Time frame: At the time of enrollment

    Thyroid stimulating hormone (TSH) (µIU/mL) - To evaluate thyroid-related causes of fatigue.

  11. Assessment of C-reactive protein (CRP)

    Time frame: At the time of enrollment

    C-reactive protein (CRP) (mg/L) - As a marker of systemic inflammation related to fatigue.

Sponsors and collaborators

Lead sponsor

Uşak University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 1, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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