Prediabetes and Type 2 Diabetes in Aging

NCT06953609 | Completed

• 1 other identifier: 562-562-11
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Assessing sense of direction.

  At the time of enrollment

• Reaction evaluation

  At the time of enrollment

• Assessment of Blood glucose

  At the time of the enrollment

• Assessment of Cortisol (µg/dL)

  At the enrollment

• Dual task performance assessment

  At the time of enrollment

Study Arms (4)

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Uşak Education and Research Hospital

Uşak, Uşak, 64200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Fatigue; Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevser Gursan, Dr.

  Uşak University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: May 1, 2025
• Study Start: April 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)