Prediabetes and Type 2 Diabetes in Aging

NCT ID: NCT06953609

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-08-15

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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%,

No interventions assigned to this group

A prediabetes (Impaired Glucose Tolerance)

those with a prediabetes (Impaired Glucose Tolerance) level between 5.7% and 6.4%

No interventions assigned to this group

Those with type 2 DM (controlled)

those with a HbA1c Levels of 6.5% - 7.5%

No interventions assigned to this group

Those with type 2 DM (uncontrolled)

those with an HbA1c level above 7.5

No interventions assigned to this group

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uşak University

OTHER

Sponsor Role: lead

Responsible Party

Kevser Gürsan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevser Gursan, Dr.

Role: PRINCIPAL_INVESTIGATOR

Uşak University

Locations

Uşak Education and Research Hospital

Uşak, Uşak, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

562-562-11

Identifier Type: -

Identifier Source: org_study_id