Metabolic SyndromeNCT05702437
Effect of MetS* on Cognitive Performance and Physical Activity (Metabolic Syndrome)
An observational study of Metabolic Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- assessment of cognitive performance
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2023to May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, 34093
Aysenur Erekdag, MSc, +905548959013, aysenurerekdag@gmail.com
Ayca Arslanturk, BSc, +905312891352, aycaarslanturk.06@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- assessment of cognitive performance
- Keywords
- Cognitive Function, Physical Performance, Adults, Chronic Disease
- Medical subject headings
- Metabolic Syndrome, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of cognitive performanceOther
Also called assessment of physical performance
evaluation of the cognitive and physical performance of the participants by two separate researchers at the same time
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: assessment of cognitive 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. Receives: Other: assessment of cognitive performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: once, at baseline
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.
Measured: once, at baseline
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.
Measured: once, at baseline
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.
Measured: once, at baseline
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.
Measured: once, at baseline
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/)
Measured: once, at baseline
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.
Measured: once, at baseline
Stroop Test TBAG Form
a neuropsychological test that measures focused attention and the speed of information processing
Measured: once, at baseline
Secondary outcomes (4)
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.
Measured: once, at baseline
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.
Measured: once, at baseline
International Physical Activity Questionnare Short-Form
taking into account the last week, the time spent on walking, moderate and vigorous activities is questioned.
Measured: once, at baseline
pedometer
A valid and reliable method for comparing the participants' weekly step counts and determining their physical activity levels
Measured: once, at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start20 Feb 2023
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Erekdag, Istanbul University - Cerrahpasa
- Investigators
- Ayca Arslanturk, BSc, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702437
- Sponsor's protocol ID
- 3274238910
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35054972Expert 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.
PubMed 11368702Bahchevanov 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.
PubMed 33067992Tahmi 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.
PubMed 34668083Wichayanrat 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.
PubMed 36281674
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Metabolic Syndrome and Its Components on Cognitive Performance and Physical Activity Level in Middle-age Individuals
- ClinicalTrials.gov ID
- NCT05702437
- Acronym / sponsor ID
- 3274238910
- Conditions
- Metabolic Syndrome
- Keywords
- Cognitive Function, Physical Performance, Adults, Chronic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MetS Group | – | Other: assessment of cognitive performanceit 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. |
| Control Group | – | Other: assessment of cognitive performanceit 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of cognitive performanceAlso: assessment of physical performanceevaluation of the cognitive and physical performance of the participants by two separate researchers at the same time | Other | Control Group, MetS Group |
Primary outcome
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.
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.
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.
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.
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.
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/)
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.
Stroop Test TBAG Form
Time frame: once, at baseline
a neuropsychological test that measures focused attention and the speed of information processing
4 secondary outcomes
Mini Mental State Examination
Time frame: once, at baseline
Visual Reaction Test
Time frame: once, at baseline
International Physical Activity Questionnare Short-Form
Time frame: once, at baseline
pedometer
Time frame: once, at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 35054972Fahed 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.
- Background: PubMed 11368702Expert 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.
- Background: PubMed 33067992Bahchevanov 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.
- Background: PubMed 34668083Tahmi 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.
- Background: PubMed 36281674Wichayanrat 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.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayca Arslanturk, BSc principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysenur Erekdag, MSc (+905548959013, aysenurerekdag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Metabolic Syndrome-waist circumference (time frame: once, at baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702437, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.