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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05702437
• Other study ID #: 3274238910
• Status: Recruiting
• Start date: February 20, 2023
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Aysenur Erekdag, MSc
• Phone: +905548959013
• Email: aysenurerekdag[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Bahchevanov KM, Dzhambov AM, Chompalov KA, Massaldjieva RI, Atanassova PA, Mitkov MD. Contribution of Components of Metabolic Syndrome to Cognitive Performance in Middle-Aged Adults. Arch Clin Neuropsychol. 2021 May 21;36(4):498-506. doi: 10.1093/arclin/acaa081. — View Citation

Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available. — View Citation

Fahed G, Aoun L, Bou Zerdan M, Allam S, Bou Zerdan M, Bouferraa Y, Assi HI. Metabolic Syndrome: Updates on Pathophysiology and Management in 2021. Int J Mol Sci. 2022 Jan 12;23(2):786. doi: 10.3390/ijms23020786. — View Citation

Tahmi M, Palta P, Luchsinger JA. Metabolic Syndrome and Cognitive Function. Curr Cardiol Rep. 2021 Oct 19;23(12):180. doi: 10.1007/s11886-021-01615-y. — View Citation

Wichayanrat W, Boripuntakul S, Keawtep P, Worakul P, Sungkarat S. Obesity and Brain Health: The Impact of Metabolic Syndrome and Cardiorespiratory Fitness on Cognitive Performances in Middle-Aged Obese Women. J Prev Alzheimers Dis. 2022;9(4):701-707. doi: 10.14283/jpad.2022.54. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Metabolic Syndrome-waist circumference	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
Primary	Evaluation of Metabolic Syndrome-blood pressure	"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
Primary	Evaluation of Metabolic Syndrome-triglyceride	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
Primary	Evaluation of Metabolic Syndrome-HDL-C	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
Primary	Evaluation of Metabolic Syndrome-fasting plasma level	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
Primary	Metabolic Syndrome Severity Score	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
Primary	Monreal Cognitive Assessment	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
Primary	Stroop Test TBAG Form	a neuropsychological test that measures focused attention and the speed of information processing	once, at baseline
Secondary	Mini Mental State Examination	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
Secondary	Visual Reaction Test	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
Secondary	International Physical Activity Questionnare Short-Form	taking into account the last week, the time spent on walking, moderate and vigorous activities is questioned.	once, at baseline
Secondary	pedometer	A valid and reliable method for comparing the participants' weekly step counts and determining their physical activity levels	once, at baseline