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临床试验/NCT05702437
NCT05702437招募中不适用

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

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2023年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
82
试验地点
1
主要终点
Evaluation of Metabolic Syndrome-blood pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Evaluation of Metabolic Syndrome-blood pressure

时间窗: 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.

Evaluation of Metabolic Syndrome-waist circumference

时间窗: 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.

Evaluation of Metabolic Syndrome-HDL-C

时间窗: 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.

Evaluation of Metabolic Syndrome-fasting plasma level

时间窗: 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.

Metabolic Syndrome Severity Score

时间窗: 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/)

Evaluation of Metabolic Syndrome-triglyceride

时间窗: 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.

Monreal Cognitive Assessment

时间窗: 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.

Stroop Test TBAG Form

时间窗: once, at baseline

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

次要结局

  • International Physical Activity Questionnare Short-Form(once, at baseline)
  • Mini Mental State Examination(once, at baseline)
  • Visual Reaction Test(once, at baseline)
  • pedometer(once, at baseline)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysenur Erekdag

Investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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