Assessment of Cognitive Function and Functional Performance in Patients With Type 2 Diabetes
NCT07390292, Not yet recruiting, Bezmialem Vakif University
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Assessment of Cognitive Function and Functional Performance in Patients With Type 2 Diabetes | ClinicalTrials.gov |
| NCT number | NCT07390292 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Bezmialem Vakif University | ClinicalTrials.gov |
| Conditions | Type 2 Diabetes | ClinicalTrials.gov |
| Interventions | No intervention (observational study) | ClinicalTrials.gov |
| First posted | 2026-02-05 | ClinicalTrials.gov |
| Last updated | 2026-02-05 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Postural Stability | Single assessment at baseline | 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. | ClinicalTrials.gov |
| Primary | Limits of Stability | Single assessment at baseline | 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. | ClinicalTrials.gov |
| Primary | Sensory Integration of Balance | Single assessment at baseline | 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. | ClinicalTrials.gov |
| Secondary | Stroop Test | Single assessment at baseline | The Stroop Test is used to assess cognitive function, including processing speed, selective attention, cognitive flexibility, and the ability to inhibit automatic responses.The test consists of three parts, in which participants are required to perform color-word tasks. The completion time of the test will be recorded in seconds. | ClinicalTrials.gov |
| Secondary | Mini-Mental State Examination (MMSE) | Single assessment at baseline | The Mini-Mental State Examination (MMSE) will be used to assess general cognitive function. The test evaluates the domains of orientation, attention, memory, calculation, and language. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. | ClinicalTrials.gov |
| Secondary | Four Square Step Test | Single assessment at baseline | It is used to assess dynamic balance during obstacle negotiation. The patient is instructed to step over four canes placed on the floor in a cross configuration, following a specified sequence. The completion time of the test is recorded in seconds. | ClinicalTrials.gov |
| Secondary | Assessment of Functional Capacity | Single assessment at baseline | Functional capacity will be assessed using the 6-minute walk test. This test involves participants walking along a 30-meter corridor at their own pace for six minutes, with the distance recorded in meters. At the end of six minutes, the participant is informed that the test is complete and the test is terminated. The expected average walking distance for healthy individuals ranges from 400 to 700 meters. | ClinicalTrials.gov |
| Secondary | 30 Second Sit to Stand Test | Single assessment at baseline | Lower extremity muscle strength will be assessed using the 30-second chair stand test. During the test, participants will be instructed to stand up from a chair for 30 seconds with their arms crossed over their chest and their feet flat on the floor. The number of completed stands will be recorded to evaluate functional lower extremity muscle strength. | ClinicalTrials.gov |
| Secondary | Quadriceps Femoris Muscle Strength | Single assessment at baseline | Quadriceps femoris muscle strength will be assessed using an electronic hand-held dynamometer.Participants will be instructed to sit with the knee in full extension, while the physiotherapist applies maximal resistance at the ankle to evaluate the isometric strength of the quadriceps femoris muscle.The muscle strength value will be recorded in kilograms (kg). | ClinicalTrials.gov |
| Secondary | Falls Efficacy Scale-International (FES-I) | Single assessment at baseline | To assess fear of falling, fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I).The scale consists of 16 items that assess individuals' levels of concern related to falling during daily activities.Each item is scored from 1 (not at all concerned) to 4 (very concerned). The total score will be recorded. | ClinicalTrials.gov |
| Secondary | Functional Reach Test | Single assessment at baseline | The Functional Reach Test is performed to assess fall risk. During the test, participants are instructed to stand, raise the arm to approximately 90 degrees, and reach forward as far as possible without stepping or losing balance.The distance between the starting position of the hand and the furthest point reached is recorded in centimeters (cm).Values of 15 cm or less indicate an increased risk of falling. | ClinicalTrials.gov |
| Secondary | Timed Up and Go (TUG) Test | Single assessment at baseline | The Timed Up and Go (TUG) Test is performed to assess fall risk. The test requires a chair and a stopwatch. A 3-meter distance is marked in front of the chair, and participants are instructed to stand up from the chair on the command "go," walk this distance at a normal pace, and sit down again. The completion time of the test is recorded in seconds. Longer completion times are associated with an increased risk of falling. | ClinicalTrials.gov |
| Secondary | Assessment of Quality of Life | Single assessment at baseline | Quality of life will be assessed using the WHOQOL-BREF questionnaire. The WHOQOL-BREF consists of four domains: physical health (7 items), psychological well-being (6 items), social relationships (3 items), and environmental health (8 items). All items are rated on a 5-point Likert scale and scored from 1 to 5. | ClinicalTrials.gov |
| Secondary | Body Mass İndex | Single assessment at baseline | Body mass index will be taken into consideration during evaluation. Body height (m) will be measured using standardized procedures, and body weight (kg) will be measured using the Omron BF511 Body Composition Monitor. Body Mass Index (BMI) will be calculated by dividing body weight (kg) by the square of height in meters (kg/m²). | ClinicalTrials.gov |
| Secondary | Body Fat Mass (kg) | Single assessment at baseline | Body fat mass (kg) will be measured using the Omron BF511 Body Composition Monitor according to the standard protocol of the device. | ClinicalTrials.gov |
| Secondary | Skeletal Muscle Mass (kg) | Single assessment at baseline | Skeletal muscle mass (kg) will be measured using the Omron BF511 Body Composition Monitor according to the standard protocol of the device. | ClinicalTrials.gov |
| Secondary | Resting Metabolic Rate | Single assessment at baseline | Resting metabolic rate (kcal) will be assessed using the Omron BF511 Body Composition Monitor. | ClinicalTrials.gov |
| Secondary | Visceral Fat Level | Single assessment at baseline | Visceral fat level will be assessed using the Omron BF511 Body Composition Monitor according to the manufacturer's instructions. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)