Clinical trial NCT05203042: Comparison of Cognitive and Motor Dual Task Performance in Individuals With Prediabetes and Diabetes
Official title: Comparison of Cognitive and Motor Dual Task Performance in Individuals With Prediabetes and Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Keywords: Diabetes
Prediabetes
Double task performance
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Ministry of Health, Karabük Provincial Health Directorate, Barış Family Health Center / 780520 Health Center Safranbolu / Karabük center applied to the center, Dr. Patients over the age of 65 who volunteered to participate in the study, who were followed up by Hasan Hüseyin Mermerkaya, who came on a routine basis, had a blood test within a maximum of 6 months, and were diagnosed with type 2 diabetes or prediabetes, will be included in the study.

Brief summary: The aim of this study is to compare the dual task task in individuals with prediabetes and diabetes. According to the results of this study, if there is a difference in dual-task performances and other conditions between people with prediabetes and people with diabetes, it will be a reference study for intervention studies accordingly.

Detailed description: Diabetes is a chronic, broad-spectrum metabolic disorder that requires continuous medical care, in which the organism cannot adequately benefit from carbohydrates, fats and proteins due to insulin deficiency or defects in the effect of insulin. The number of diabetes cases worldwide has increased rapidly over the past four decades, rising from 108 million in 1980 to 422 million in 2014 . An aging population, physical inactivity, and rising obesity rates are recognized as driving factors for the rapid growth of diabetes . Diabetes is a leading cause of mortality and is a strong risk factor for both microvascular and macrovascular complications . Adequate glycemic control, cardiovascular risk factors management, early treatment of complications and related comorbidities are required for appropriate Type 2 Diabetes management . Complications of Type 2 Diabetes include heart and blood vessel disease, neuropathy, kidney disease, skin and eye damage, sleep apnea, bone metabolism disorders, mood disorders, and cognitive impairment. Therefore, it is essential to maintain a healthy lifestyle with weight control, balanced diet, smoking cessation, and physical activity The concept of prediabetes includes individuals who do not meet the criteria for a diagnosis of diabetes, but whose blood sugar is above normal limits. In other words, it can be called the pre-diabetic period when glucose metabolism begins to deteriorate. In a study conducted by the Centers for Disease Control and Prevention (CDC) in the United States in 2014, it was shown that there are 29 million adults with diabetes and 86 million adults with prediabetes in the United States. In another study, it was predicted that there would be more than 470 million individuals with prediabetes worldwide in 2030. Prediabetic individuals are more likely to develop diabetes than healthy individuals. Although the rate of progression varies in the literature, it has been reported that 5-10% of prediabetic individuals become diabetic every year. At the same time, many studies conducted around the world have shown that the risk of many comorbidities in diabetes and prediabetes is the same and affects all age groups. In conclusion, prediabetes is a toxic cardiometabolic condition associated with an increased risk for microvascular and macrovascular complications. Given the millions of people with prediabetes worldwide, identifying and responding to at-risk prediabetic populations is critical to contain the increased risks of cardiometabolic disease and conversion rates to diabetes.In a 10-year follow-up study conducted in prediabetes and diabetics, a linear relationship was found between individuals' HbA1c levels and cognitive decline. At the same time, evidence has shown that poor glycemic control is strongly associated with the development of cognitive dysfunction. Cerebral and peripheral vascular complications (eg, neuropathy, white matter disease, stroke, myocardial infarction, peripheral artery disease) that develop as a result of chronic exposure to hyperglycemia have been associated with cognitive impairment in Type 2 diabetes. Affected cognitive areas are reported as decreased psychomotor speed, impaired memory, executive processes, and attention. Executive processes are "higher-level" functions that monitor and control other cognitive processes. These capacities are thought to underlie activities such as planning, making decisions, switching tasks, goal-directed behavior, and coordinating ongoing activities (for example, doing two things at once or planning a series of activities). More importantly, it is critical for sensory integration used to coordinate executive function, balance, and gait motor output.Dual task paradigms are used to examine the degree of automaticity of movement. In these paradigms, a primary task is undertaken, often such as walking, which is the main focus of attention. Secondary tasks are added and the resulting impact on both tasks is examined. In everyday situations it is normal to undertake multiple tasks at once, such as walking and talking, so these situations are essentially dual-task paradigms. If two (or more) tasks undertaken together exceed the available attention capacity, there will be insufficient capacity to optimally perform both tasks and the performance of one or both of the tasks will deteriorate. Impairments in executive function lead to the dual-task paradigm. Dual tasks can be motor-cognitive, cognitive-cognitive, or motor-motor. In a previous study, a negative effect of dual assignment on gait parameters in Type 2 diabetes was observed. It suggests that impaired dual-task capacity in type 2 diabetes may explain the higher incidence of falls in this populationGiven the changes in cognitive function identified in people with poor glycemic control, dual-task testing may provide a functional biomarker for movement impairment and fall risk. A previously published meta-analysis suggested that dual-task testing in people with diabetes better emphasizes deficiencies in functional performance rather than single-task testing, and that dual-task testing can be used to identify people who will start rehabilitation interventions to improve functional performance and reduce the risk of falls. However, although cognitive function declines are common in prediabetic individuals, dual-task performance has not been evaluated and compared with diabetic individuals in previous studies to show the effect of these declines on functional performance. Therefore, the aim of this study is to compare cognitive and motor dual-task performance in individuals with prediabetes and diabetes.

Eligibility criteria: Inclusion Criteria:

* be 65 years or older
* Being diagnosed with type 2 diabetes or prediabetes
* Volunteer to participate in the study
* Ability to participate in tests independently
* Getting a score of 24 or higher on the Mini Mental State Test
* Being literate
* Being able to communicate

Exclusion Criteria:

* Cancer patients known to be life-threatening
* Severe respiratory, central, vascular, peripheral and uncontrolled metabolic problems
* Using drugs known to affect the postural control system (eg benzodiazepines)
* Those with peripheral neuropathy
* Those with severe hearing and visual impairments

Primary outcomes:
measure: Timed Get Up and Go Test-Motor and Cognitive Task:
timeFrame: 15 minutes
Secondary outcomes:
measure: Short Physical Performance Battery:
timeFrame: 10 minutes
measure: Muscle Strength Measurement
timeFrame: 5 minutes
measure: Mini Mental State Test
timeFrame: 10 minutes
measure: Fatigue Assessment
timeFrame: 2 minutes
measure: Pain Assessment
timeFrame: 2 minutes
measure: Biochemical Analysis
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
References:
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