Clinical trial NCT05569642: Cluster Analysis to Identify Metabolic Syndrome Components and Physical Fitness in Patients With Metabolic Syndrome
Official title: A Study of Cluster Analysis to Identify Metabolic Syndrome Components and Physical Fitness in Patients With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Keywords: MetS, physical fitness, physical activity, cluster analysis
Lead sponsor: Istanbul Galata University
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 112
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers between the ages of 40-65, who have been diagnosed with MetS on the basis of type 2 diabetes for at least one year by an Internal Medicine Specialist, applying to the Department of Endocrinology and Metabolism Diseases, Department of Internal Medicine, Istanbul University, Istanbul Medical Faculty, will be included in the study.

Brief summary: The components of MetS (abdominal obesity, high blood pressure, high serum glucose, high triglyceride level and low HDL-C) differ according to demographic characteristics such as age, gender and comorbidities. Low physical activity level, genetic makeup, nutritional disorders, decreased muscle strength and low cardiorespiratory fitness can be counted among the risk factors associated with MetS. In our study, it was aimed to examine the relationship between the components of the MetS and muscle strength, physical activity, functional capacity and quality of life. Our secondary aim is to investigate the independent effects of different components of MetS on each parameter.

Detailed description: The participants' sociodemographic characteristics such as age, height, weight, body mass index, waist circumference, marital status and education level, and anthropometric measurements, body fat percentage distributions, fasting blood glucose, HbA1c and lipid profiles will be recorded from previous analysis reports. Lower extremity quadriceps muscle strength Hand-held dynamometer, grip strength hand dynamometer, physical activity level International Physical Activity Questionnaire-Short Form-IPAQ-SF, number of steps pedometer, functional capacity 6 minute walking test and quality of life will be evaluated with the European Quality of Life Scale-5 Dimension.

Eligibility criteria: Inclusion Criteria:

* To be diagnosed with MetS by an Internal Medicine Specialist according to NCEP-ATP III criteria
* Finding abdominal obesity component according to TURDEP-II criteria
* Being between the ages of 40-65
* To be able to read and write Turkish
* Having signed the informed consent form

Exclusion Criteria:

* Lack of cooperation
* Those with severe peripheral or central neurological disorders
* Patients with uncontrolled hypertension and uncontrolled arrhythmia
* Pregnant or breastfeeding patients
* Those with diabetic ulcer or neuropathy
* Chronic kidney failure (eGFR\<30 ml/min)
* Chronic liver disease (ALT/AST\<3X Normal upper limit)
* Those with serious respiratory system disease
* Patients with cardiac pacemaker
* History of previous stroke or myocardial infarction
* Presence of lower and upper extremity orthopedic problems that may prevent the application of clinical tests

Primary outcomes:
measure: Measurement of Lower Extremity Muscle Strength
timeFrame: 7 minutes.
measure: The 6-minute walking test (6MWT)
timeFrame: 6 minutes.
measure: Physical activity levels of individuals will be determined by IPAQ-SF scale
timeFrame: 8 minutes.
measure: Measurement of step counts by Pedometers
timeFrame: The participant's step count will be tracked for 7 days.
measure: Grip Strength Measurement
timeFrame: 5 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Endocrinology and Metabolic Diseases
Study officials:
References: