Assessment of Cognitive Function and Functional Performance in Patients With Type 2 Diabetes

NCT07390292 | Not Yet Recruiting

• 1 other identifier: 2025/251
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes is a chronic metabolic disease that is becoming a growing public health problem worldwide, affecting people's lives in many ways. It is characterized by impaired carbohydrate, lipid, and protein metabolism associated with insufficient insulin secretion and/or reduced sensitivity to the metabolic effects of insulin.Along with diabetes, many complications may develop in affected individuals. Cognitive impairments are now also considered an important and common complication of diabetes.The aim of this study is to investigate the effects of cognitive function levels on functional capacity, balance, fear of falling, and quality of life in individuals with type 2 diabetes.In this context, participants' cognitive function levels will be assessed using the Mini-Mental State Examination and the Stroop Test. Functional capacity will be evaluated using the 6-Minute Walk Test. Balance performance will be assessed using the Biodex Balance System and the Four Square Step Test. Lower extremity muscle strength will be measured using a digital hand-held dynamometer and the 30-Second Sit-to-Stand Test. Fear of falling will be evaluated using the Falls Efficacy Scale-International (FES-I), the Functional Reach Test, and the Timed Up and Go (TUG) Test. Participants' quality of life will be assessed using the WHOQOL-BREF quality of life questionnaire.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes Mellitus; Cognitive Function; Balance; Functional Capacity

Outcome Measures

Primary Outcomes (3)

• Postural Stability

  Postural stability will be assessed using the Biodex Balance System®. This assessment is performed to evaluate the individual's ability to maintain the center of body mass. Deviations from the center of balance will be recorded during the test. Higher stability index scores indicate greater deviation from the center of balance and poorer postural stability.

  Single assessment at baseline

• Limits of Stability

  This assessment will be conducted using the Biodex Balance System®. The test will be performed on a static platform. The purpose of the test is to evaluate the individual's ability to shift and control the center of body mass within the base of support. Directional control (overall, forward, backward, left, right, forward/left, forward/right, backward/left, backward/right) will be assessed and expressed as a percentage (%). Higher scores are associated with better postural control.

  Single assessment at baseline

• Sensory Integration of Balance

  This assessment will be conducted using the Biodex Balance System®. The purpose of the test is to evaluate how different sensory inputs contribute to the maintenance of balance and how well balance can be preserved when one or more of these sensory inputs are removed. The test will be performed under the following conditions: eyes open and eyes closed on a firm surface, and eyes open and eyes closed on a foam surface. A sway index will be calculated for each condition.

  Single assessment at baseline

Secondary Outcomes (15)

• Stroop Test

  Single assessment at baseline

• Mini-Mental State Examination (MMSE)

  Single assessment at baseline

• Four Square Step Test

  Single assessment at baseline

• Assessment of Functional Capacity

  Single assessment at baseline

• 30 Second Sit to Stand Test

  Single assessment at baseline

Study Arms (2)

Type 2 Diabetes Mellitus Group

Other: No intervention (observational study)

Healthy Control Group

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

This is an observational study. No treatment was applied to the individuals. The study will evaluate the individuals' cognitive functions and functional capacities, balance, fear of falling, and quality of life.

Healthy Control Group; Type 2 Diabetes Mellitus Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted at Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, including the Pulmonary Physiotherapy and Rehabilitation Education and Research Laboratory and the Cardiac Physiotherapy and Rehabilitation Education and Research Laboratory, using face-to-face interview methods with the participants.

You may qualify if:

• Being between 40 and 65 years of age
• Having an HbA1c level between 6.5 and 11
• Having been diagnosed with diabetes for at least 1 year
• Scoring 24 or higher on the Mini-Mental State Examination
• Being able to walk independently without assistance
• Having provided voluntary participation and signed written informed consent

You may not qualify if:

• Having a diagnosis of any neurological or psychiatric disorder (e.g., hemiplegia, Alzheimer's disease, Parkinson's disease)
• Having uncontrolled hypertension and/or uncontrolled cardiac arrhythmia
• Having vertigo or other vestibular system disorders
• Having major musculoskeletal disorders
• Having undergone percutaneous transluminal coronary angioplasty or having a cardiac pacemaker
• Being pregnant
• Being unable to read or write in Turkish

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

TU (1)