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

January 11, 2024 updated by: Aysenur Erekdag, Istanbul University - Cerrahpasa (IUC)

The Effects of Metabolic Syndrome and Its Components on Cognitive Performance and Physical Activity Level in Middle-age Individuals

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Men and women who have been diagnosed with MetS according to NCEP-ATP III criteria and healthy individuals who do not have any health problems

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Metabolic Syndrome-waist circumference
Time Frame: 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.
once, at baseline
Evaluation of Metabolic Syndrome-blood pressure
Time Frame: 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.
once, at baseline
Evaluation of Metabolic Syndrome-triglyceride
Time Frame: 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.
once, at baseline
Evaluation of Metabolic Syndrome-HDL-C
Time Frame: 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.
once, at baseline
Evaluation of Metabolic Syndrome-fasting plasma level
Time Frame: 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.
once, at baseline
Metabolic Syndrome Severity Score
Time Frame: 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/)
once, at baseline
Monreal Cognitive Assessment
Time Frame: 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.
once, at baseline
Stroop Test TBAG Form
Time Frame: once, at baseline
a neuropsychological test that measures focused attention and the speed of information processing
once, at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Mental State Examination
Time Frame: 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.
once, at baseline
Visual Reaction Test
Time Frame: 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.
once, at baseline
International Physical Activity Questionnare Short-Form
Time Frame: once, at baseline
taking into account the last week, the time spent on walking, moderate and vigorous activities is questioned.
once, at baseline
pedometer
Time Frame: once, at baseline
A valid and reliable method for comparing the participants' weekly step counts and determining their physical activity levels
once, at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 15, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3274238910

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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