Effect of MetS* on Cognitive Performance and Physical Activity (Metabolic Syndrome)

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05702437
Collaborator
(none)
82
1
9
9.1

Study Details

Study Description

Brief Summary

Metabolic syndrome (MetS) increases the risk of developing diabetes and cardiovascular disease risk factors that are linked with each other, which is a metabolic dysfunction, which contains a combination of multiple.

It is known that METS plays a role in the development of many diseases such as cardiovascular diseases, stroke, cancer, Alzheimer's. Studies have revealed that neuroinflammation, oxidative stress, abnormal lipid metabolism and impaired vascularization, which play a role in the pathogenesis of MetS, affect the structure of the brain and cognition. Atherosclerosis of the carotid artery, increased brain atrophy and white matter damage are potential explanatory mechanisms that lead to an impact on cognitive skills in patients with MetS. In addition, the existence of MetS components such as obesity, diabetes, hypertension alone also negatively affects cognitive functions, and the level of cognitive influence also increases as the number of components an individual has increases.

The literature reports that learning, executive functions, processing speed, attention/working memory and global cognitive functions are affected in individuals with MetS, but no consensus has been reached on this issue. Some studies say that MetS causes a significant decrease in cognitive functions, while some studies indicate that this difference is not significant.

The aim of our study is to proof the relationship between MetS and cognitive functions with metabolic syndrome components.

H1:There is a relationship between the MetS and cognitive functions.

Condition or Disease Intervention/Treatment Phase
  • Other: assessment of cognitive performance

Detailed Description

Voluntary participants who have been diagnosed with MetS and agreed to voluntary health subjects will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. There will be individuals diagnosed with MetS in the intervention group and healthy individuals who do not have any problems in the control group.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
82 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effects of Metabolic Syndrome and Its Components on Cognitive Performance and Physical Activity Level in Middle-age Individuals
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
MetS Group

it consists of volunteer participants diagnosed with MetS between the ages of 18 and 50. All assessments will be applied to the participants by two different researchers at the same time.

Other: assessment of cognitive performance
evaluation of the cognitive and physical performance of the participants by two separate researchers at the same time
Other Names:
  • assessment of physical performance
  • Control Group

    it will consist of healthy individuals aged 18-50 who do not have any health problems and have volunteered to participate in the study who have undergone a health check within the last 6 months.

    Other: assessment of cognitive performance
    evaluation of the cognitive and physical performance of the participants by two separate researchers at the same time
    Other Names:
  • assessment of physical performance
  • Outcome Measures

    Primary Outcome Measures

    1. Evaluation of Metabolic Syndrome-waist circumference [once, at baseline]

      Waist Circumference measurement will be recorded with a tape measure in the middle between the last palpable rib and the upper edge of the iliac crest.

    2. Evaluation of Metabolic Syndrome-blood pressure [once, at baseline]

      "Omron" digital blood pressure monitor will be used to measure systolic and diastolic blood pressure. Participants will be asked to rest for 5 minutes before the measurement.

    3. Evaluation of Metabolic Syndrome-triglyceride [once, at baseline]

      Triglyceride, HDL-C and fasting plasma levels and biochemistry laboratory findings of individuals will be evaluated. Before the analysis, 8-12 hours of fasting is required so that it does not affect the test results.

    4. Evaluation of Metabolic Syndrome-HDL-C [once, at baseline]

      Triglyceride, HDL-C and fasting plasma levels and biochemistry laboratory findings of individuals will be evaluated. Before the analysis, 8-12 hours of fasting is required so that it does not affect the test results.

    5. Evaluation of Metabolic Syndrome-fasting plasma level [once, at baseline]

      Triglyceride, HDL-C and fasting plasma levels and biochemistry laboratory findings of individuals will be evaluated. Before the analysis, 8-12 hours of fasting is required so that it does not affect the test results.

    6. Metabolic Syndrome Severity Score [once, at baseline]

      This scoring creates a z-score by considering factors such as age, race, gender, and metabolic syndrome components values. There is a website that automatically calculates the z-score when these data are entered. (https://metscalc.org/metscalc/)

    7. Monreal Cognitive Assessment [once, at baseline]

      This scale consists of parts that evaluate executive functions, attention and concentration, memory, language, abstract thinking, visual-spatial skills, orientation and calculation. The application of MoCA takes about 10 minutes and the total score of the scale is calculated over 30 points. The threshold point value is 21. Scores of 20 or less are considered cognitive dysfunction.

    8. Stroop Test TBAG Form [once, at baseline]

      a neuropsychological test that measures focused attention and the speed of information processing

    Secondary Outcome Measures

    1. Mini Mental State Examination [once, at baseline]

      it is a test consisting of 11 questions that evaluate different cognitive parameters, including recording memory, attention and calculation, recall and language, motor function and perception. The maximum score that can be taken from the test is 30 and there is no time limit. In scoring, 24-30 points are normal, 23 points and below indicate mild cognitive impairment.

    2. Visual Reaction Test [once, at baseline]

      the participant sees a red circle appearing on a white screen on the computer at variable time intervals and should press the December key of the computer quickly as soon as he sees the circle.

    3. International Physical Activity Questionnare Short-Form [once, at baseline]

      taking into account the last week, the time spent on walking, moderate and vigorous activities is questioned.

    4. pedometer [once, at baseline]

      A valid and reliable method for comparing the participants' weekly step counts and determining their physical activity levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • being between the ages of 18-50

    • Having been educated for at least 5 years and know how to read and write

    • Having been diagnosed with MetS by meeting 3 of the NCEP-ATP III criteria (for participants in the MetS Group)

    • To have a biochemistry test performed within the last 6 months (for the Healthy Group)

    • Not having any MetS components (For the Healthy Group)

    Exclusion Criteria:
    • Having any neurological, psychiatric and psychological diseases that may affect cognitive status

    • Taking antipsychiatric medication

    • The presence of any visual-auditory intellectual disability

    • Having undergone bariatric surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bezmialem Vakif University Istanbul Turkey 34093

    Sponsors and Collaborators

    • Istanbul University - Cerrahpasa (IUC)

    Investigators

    • Principal Investigator: Ayca Arslanturk, BSc, Bezmialem Vakif University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Aysenur Erekdag, Investigator, Istanbul University - Cerrahpasa (IUC)
    ClinicalTrials.gov Identifier:
    NCT05702437
    Other Study ID Numbers:
    • 3274238910
    First Posted:
    Jan 27, 2023
    Last Update Posted:
    Jan 27, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aysenur Erekdag, Investigator, Istanbul University - Cerrahpasa (IUC)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 27, 2023