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

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Cognitive Function; Prediabetes; Type 2 Diabetes Mellitus (T2DM); Dual Task

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 Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Uşak
    • Uşak, Uşak, Turkey (Türkiye), 64200
      • Uşak Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the time of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At the time of enrollment
Assessment of Blood glucose	Blood glucose (mg/dL) - To explore the relationship between glycemic status and fatigue.	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.	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	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.	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.	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.	At the time of enrollment
Assessment of Serum ferritin	Serum ferritin (ng/mL) - To assess iron stores which may influence fatigue levels.	At the time of enrollment
Assessment of Thyroid stimulating hormone (TSH)	Thyroid stimulating hormone (TSH) (µIU/mL) - To evaluate thyroid-related causes of fatigue.	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.	At the time of enrollment

Collaborators and Investigators

• Sponsor: Uşak University
• Investigators: Principal Investigator: Kevser Gursan, Dr., Uşak University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): August 15, 2025

Study Registration Dates

• First Submitted: April 19, 2025
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: fatigue; cognitive function; type 2 diabetes mellitus; prediabetes; dual task
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Diabetes Mellitus, Type 2; Fatigue; Prediabetic State
• Other Study ID Numbers: 562-562-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No