Clinical trial NCT06953609: Prediabetes and Type 2 Diabetes in Aging
Official title: Effects of Prediabetes and Type 2 Diabetes on Cognitive Status, Physical Function, and Fatigue in Geriatric Individuals: A Case-Control Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Type 2 Diabetes Mellitus (T2DM)
Cognitive Function
Dual Task
Fatigue
Prediabetes
Keywords: type 2 diabetes mellitus
cognitive function
dual task
fatigue
prediabetes
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive status assessment
timeFrame: At the time of enrollment
Secondary outcomes:
measure: Assessing sense of direction.
timeFrame: At the time of enrollment
measure: Reaction evaluation
timeFrame: At the time of enrollment
measure: Assessment of Blood glucose
timeFrame: At the time of the enrollment
measure: Assessment of Cortisol (µg/dL)
timeFrame: At the enrollment
measure: Dual task performance assessment
timeFrame: At the time of enrollment
measure: Physical Function Assessment
timeFrame: At the time of enrollment
measure: Self-report assessment of fatigue
timeFrame: At the time of enrollment
measure: Assessment of Hemoglobin level
timeFrame: At the time of enrollment
measure: Assessment of Serum ferritin
timeFrame: At the time of enrollment
measure: Assessment of Thyroid stimulating hormone (TSH)
timeFrame: At the time of enrollment
measure: Assessment of C-reactive protein (CRP)
timeFrame: At the time of enrollment
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Uşak Education and Research Hospital
Study officials:
affiliation: Uşak University
name: Kevser Gursan, Dr.
role: PRINCIPAL_INVESTIGATOR
References: