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Sponsor study identifier
observational
100
1 country
1
Study Start
March 1, 2020
Actual (reported)Primary Completion
December 24, 2021
Actual (reported)Study Completion
December 24, 2021
Actual (reported)Obesity can be defined as' a disease that occurs as a result of the energy (calorie) taken with food being more than the energy consumed and the excess energy being stored as fat in the body, negatively affecting the quality and duration of life. BMI is calculated by dividing the weight (kg) by the square of the height (m2) (1,2). According to the World Health Organization (WHO) classification, BMI between 25-29.9 kg / m2 is overweight, 30-34.9 kg / m2 is light, 35-39.9 kg / m2 is medium, 40 kg / m2 and above is considered as severe obesity. Obesity has important effects on respiratory function. These mechanical and biochemical effects are not easily measured by pulmonary function test and BMI measurement.Changes caused by mediators produced by adipose tissue likely cause changes in lung function, but this effect is not fully understood at the moment. The aim of our study is to make these effects more understandable and to compare them with different obesity classes and people with normal weight who are considered healthy. Hypothesis 0: The effects of obesity on respiratory functions and multidimensional health-related parameters do not show a statistically significant difference compared to individuals with different levels of the disease and normal weight individuals classified as healthy. Hypothesis 1: The effects of obesity on respiratory functions and multidimensional health-related parameters show a statistically significant difference compared to people with different levels of the disease and normal weight individuals classified as healthy. The study will be carried out by face-to-face evaluations in a clinical setting with obese patients between the ages of 18-65 who have applied to the clinic with a diagnosis of obesity and agree to participate in the study, and healthy volunteers who are considered to be healthy without a diagnosis of obesity. Looking at the evaluations to be made; Measurement of respiratory function parameters, measurement of respiratory muscle strength, anthropometric measurements, evaluation of body composition, quality of life, upper extremity muscle strength and grip strength, lower extremity muscle strength, fatigue evaluation, vital signs, evaluation of exercise perception, presence of dyspnea and its level will be evaluated. A detailed description of these evaluations and the parameters to be used will be explained in detail in the next step.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 24, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2020
Actual (reported)February 23, 2021
Actual (reported)March 4, 2021
Actual (reported)December 24, 2021
Actual (reported)December 24, 2021
Actual (reported)Respiratory Function Parameters
The respiratory function parameters of the participants will be measured with a pulmonary function test using a spirometer. With these tests, the static and dynamic lung volumes and functional status of the person will be determined. Spirometric measurements will be carried out by applying the guidelines for standardization of pulmonary function tests prepared by the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Day 1.
Respiratory Muscle Strength
Day 1.
Measurement of Quality of Life
Day 1.
Group I will include cases classified as normal weight (healthy) with a body mass index of 18.5-24.9 kg / m2 as a result of the classification made by the World Health Organization. All parameter and evaluation measurements determined for this group will be made. Since this group was not considered as obese, it was determined as the control group.
Group II will include cases classified as overweight and having a body mass index of 25.0-29.9 kg / m2 as a result of the classification made by the World Health Organization. All parameter and evaluation measurements determined in this group will be made.
Group III will include cases classified as class I obese, with a body mass index of 30.0-34.9 kg / m2 as a result of the classification made by the World Health Organization. All parameter and evaluation measurements determined in this group will be made.
Group IV will include cases classified as class II obese, with a body mass index of 35.0-39.9 kg / m2 as a result of the classification made by the World Health Organization. All parameter and evaluation measurements determined in this group will be made.
Group V will include cases classified as class III (morbid) obese, with a body mass index of 40 kg / m2 as a result of the classification made by the World Health Organization. All parameter and evaluation measurements determined in this group will be made.
According to the WHO classification, the five groups to be formed will be group I normal weight (healthy), group II overweight, group III, class 1 obese, group IV, class 2 obese, group V, class 3 (morbid) obese.
Istanbul University-Cerrahpaşa Faculty of Medicine Internal Medicine Department of Endocrinology and Metabolic Diseases
Istanbul, 34098, Turkey (Türkiye)
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Gülay Aras Bayram, Phd
Medipol University
100 participants (actual enrollment reported by the registry).
First Submitted
February 23, 2021
First Posted
March 4, 2021
Study Start
March 1, 2020
Actual (reported)Perception Of Exercise
Day 1.
Anthropometric Measurements Ratios
Day 1.
Neck Circumference
Day 1.
Waist Circumference
Day 1.
Contact the study team to confirm eligibility.
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Primary Completion
December 24, 2021
Actual (reported)Study Completion
December 24, 2021
Actual (reported)Last Updated
February 15, 2022
Record last verified: 2022-02
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