Clinical trial NCT05702437: Effect of MetS* on Cognitive Performance and Physical Activity (Metabolic Syndrome)
Official title: The Effects of Metabolic Syndrome and Its Components on Cognitive Performance and Physical Activity Level in Middle-age Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Syndrome
Keywords: Cognitive Function
Physical Performance
Adults
Chronic Disease
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of Metabolic Syndrome-waist circumference
timeFrame: once, at baseline
measure: Evaluation of Metabolic Syndrome-blood pressure
timeFrame: once, at baseline
measure: Evaluation of Metabolic Syndrome-triglyceride
timeFrame: once, at baseline
measure: Evaluation of Metabolic Syndrome-HDL-C
timeFrame: once, at baseline
measure: Evaluation of Metabolic Syndrome-fasting plasma level
timeFrame: once, at baseline
measure: Metabolic Syndrome Severity Score
timeFrame: once, at baseline
measure: Monreal Cognitive Assessment
timeFrame: once, at baseline
measure: Stroop Test TBAG Form
timeFrame: once, at baseline
Secondary outcomes:
measure: Mini Mental State Examination
timeFrame: once, at baseline
measure: Visual Reaction Test
timeFrame: once, at baseline
measure: International Physical Activity Questionnare Short-Form
timeFrame: once, at baseline
measure: pedometer
timeFrame: once, at baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Ayca Arslanturk, BSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.