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Obesity, AdolescentNCT04780828

Investigation of the Effects of Different Levels of Obesity on the Respiratory System

An observational study of Obesity, Adolescent and Obesity, Morbid, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Type of treatment
Injection or infusion
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2020to 24 Dec 2021
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • Being in the age range of 18-65,
  • body mass index ≥18.5 according to the World Health Organization (WHO) classification,
  • Volunteering to participate in the study,

Who cannot join

  • Accompanying neurological or orthopedic effects that will prevent participation in the study,
  • Pregnancy status,
  • Presence of a pacemaker,
  • Having had Covid-19 disease ,
  • Having had any thoracic or abdominal surgery or injury,
  • For evaluation and control purposes Being unable to understand and apply the tests to be applied mentally and physically successfully,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpaşa Faculty of Medicine Internal Medicine Department of Endocrinology and Metabolic Diseases

    Istanbul, 34098

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Different Obesity Levels on the Respiratory System: In Our Study, Besides the Effect of Obesity on the Respiratory System, Many Different Parameters Related to Health Will be Compared.

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.

Read more

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.

Read the detailed description

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. A body mass index (BMI) of 30 or above in adults is classified as obese. BMI is calculated by dividing the weight (kg) by the square of the height (m2). 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. As the increases in BMI are related to the number of comorbidities, weight loss also affects many risk factors. It has been shown that voluntary weight loss in obese individuals over short periods (weeks or months) reduces risk factors and improves disease symptoms associated with obesity, including heart disease, Type II Diabetes mellitus, and osteoarthritis. Obesity; It is an important risk factor and disease factor for asthma, obstructive sleep apnea syndrome, obesity hypoventilation syndrome (OHS) and pulmonary hypertension diseases. The overall effect of obesity on lung function is multifactorial and is related to the mechanical and inflammatory aspects of 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.As a result of the literature review the investigators conducted, it was observed that the studies conducted in order to make more understandable the physiological and mechanical effects of obesity on different systems in the body, especially the respiratory system, were limited and inadequate in terms of numerical and targeted purposes. It was observed that lower extremity muscle strength, fatigue, sleep quality parameters were not included, and their relations with respiratory system functions and measurements were not measured. 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. Individuals who volunteered to participate in the study, who met the inclusion criteria and volunteered to participate will be evaluated by dividing them into five different groups according to the BMI parameter, in accordance with the intervals determined by WHO, and the data obtained will be compared between the groups.

Outcome Measures:

  • Measurement of Pulmonary Function Parameters: The respiratory function parameters of the participants will be measured with a respiratory function test using a spirometer. With these tests, the static and dynamic lung volumes and functional status of the person will be determined.
  • Measurement of Respiratory Muscle Strength:

It consists of respiratory muscles, diaphragm, intercostal (internal and external), scalene, sternocleidomastoid, triangularis sterni, abdominal, shoulder and neck muscles. Respiratory muscle strength can be measured in many different ways. Among the pulmonary function tests, maximum inspiratory and expiratory pressures are the measurements that are frequently used to evaluate the strength of the respiratory muscles. -Measurement of Respiratory Muscle Strength:It consists of respiratory muscles, diaphragm, intercostal (internal and external), scalene, sternocleidomastoid, triangularis sterni, abdominal, shoulder and neck muscles. Respiratory muscle strength can be measured in many different ways. Among the pulmonary function tests, maximum inspiratory and expiratory pressures are the measurements that are frequently used to evaluate the strength of the respiratory muscles. These measurements are directly related to respiratory muscle strength and help to determine the rehabilitation and exercise program by providing information about the patient's condition.

-Anthropometric Measurements: Participants' waist circumference, hip circumference, neck circumference will be measured, and their ratios (waist / height ratio, waist / hip ratio) will be calculated. Body mass index (BMI), waist circumference, and waist-to-hip ratio (B / C) is the diagnostic methods commonly used to detect adiposity. Waist circumference and waist-hip ratio have been found to be useful measurements for measuring visceral fat accumulation. Measurement of neck circumference is used as an anthropometric marker to identify patients at risk for sleep apnea syndrome. At the same time, neck circumference is thought to be associated with other metabolic diseases. In addition to these measurements, the measurement called 'New BMI' used in the literature will also be made. In this measurement, BMI is calculated with the formula 1.3 × (kg / m2).

In order to calculate the body fat ratio, it is aimed to estimate the amount of body fat with the measurement of Clinica Universidad de Navarra-Body Adiposity Estimator (CUN-BAE) in addition to the bioelectric impedance method.

BMI measurement is insufficient to determine body fat and muscle ratio. Since it is difficult to determine the location of the fat tissue in the body, it will be evaluated with the '' Body Shape Index ''.

-Assessment of Body Composition: Body composition will be measured using the method called bioelectrical impedance analysis (BIA). This measurement is based on the principles of electrical conductivity of body tissues. It is a fast, practical and relatively inexpensive method compared to other similar devices and applications used to examine the body composition of individuals. This method shows the percentage and mass of body fat, lean body weight and the amount of water in the body and their distribution percentage. The person climbs on the device and places his or her hands in the designated places. Electric current travels through the body and provides information about parameters determined by certain algorithms and calculations.

-Quality of Life: Quality of life is accepted as a multidimensional structure with many different contents. Considering the decrease in physical capacity, pain, deterioration in interpersonal relationships, decreased self-esteem, loss of self-esteem, depression, social stigma, difficulty in finding a job, rejection by the school and business environment, it is understood how low the health-related quality of life of obese individuals is. In measuring the quality of life; Nottingham Health Profile questionnaire will be used. Nottingham Health Profile is a questionnaire consisting of 7 subtitles and 45 questions, including physical, social and psychological evaluations.

-Upper Extremity Muscle Strength and Gripping Strength: It is an important parameter related to muscle strength, functional capacity, cardiovascular disease risk factors and mortality. Upper extremity muscle strength and grip strength will be measured by hand dynamometer and weight lifting tests (arm curls test).

-Lower Extremity Muscle Strength: Abnormalities that usually occur in lower extremity muscles affect patients' physical performance and daily living activities, reduce exercise tolerance and impair health-related quality of life. 30-second sit-and-go test will be used to measure lower extremity muscle strength. The score is determined by the number of times the participant sits and stands up for 30 seconds from the moment the participant is commanded to place his hands on the crossed, shoulders in the chair he is sitting with his back supported and to start in the position where his feet are in full contact with the floor.

  • Fatigue Assessment:

Fatigue is a common complaint in overweight and obese people. It has been stated that this is caused by increased body mass, decreased physical activity level and sleep disorders. In the assessment of fatigue, the Fatigue Severity Scale (39) will be used. The fatigue severity scale consists of 9 questions that question social relationship, physical performance and symptomatically the severity of fatigue. The total score is created according to the answers given to the questions.

-Vital Sign: Type 2 diabetes mellitus (T2DM), hypertension (HT), dyslipidemia (DLP), obstructive sleep apnea syndrome (OSAS) comorbidities have been associated with morbid obesity in obese individuals. Blood pressure, heart rate, oxygen saturation will be evaluated in order to observe the negative effects of these comorbidities.

-Evaluation of Exercise Perception: Aerobic exercise capacity is an essential component of physical fitness. Perceived benefits and perceived barriers to participating in physical activity will be assessed by Exercise Benefits / Barriers Scale (EBBS). It is a questionnaire consisting of 43 questions used to evaluate people's perception of exercise. Evaluates the ideas of being useful and preventive that exercise creates on people. The test score is determined by the score collected according to the answers given to the questions.

-Assessment of the Presence and Level of Dyspnea: According to the American Thoracic Society (ATS) report, the definition of dyspnea was defined as "unpleasant or uncomfortable breathing sensation and personal respiratory disturbance caused by various intensity senses" and it was stated to be a subjective feeling. "Modified Medical Research Council Scale (MMRC)" will be used to evaluate the presence of dyspnea. The MMRC is a five-item scale created on the basis of various activities that cause shortness of breath. The presence and effect of dyspnea occur according to the substance chosen by the person.

-Statistical method (s) to use: '' Hatem AM, Ismail MS, El-Hinnawy YH. 'Effect of different classes of obesity on the pulmonary functions among adult Egyptians: a cross-sectional study', Egypt J Bronchol 2019; 13: 510-5 '', the total number of samples determined for 5 groups in the sample size study, based on the FVC value and standard deviations in table 2, was calculated as 80 on the condition that it was 16 per group. Sample size calculation was made using the NCSS / PASS program. In the calculation, it was determined that the difference between the averages of the 5 groups should be 80% power and 95% confidence level to be significant. The statistical test method to be applied ANOVA will be used in conditions of normal distribution between groups, and Kruskal-Wallis test method will be used if the condition of normal distribution between groups cannot be achieved.

Keywords
Obesity, Respiratory System, Quality of Life, Anthropometric Measurements, Body Composition
Medical subject headings
Pediatric Obesity, Obesity, Morbid, Obesity, Abdominal, Body Weight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04780828
Study groupRoleWhat they receive
GROUP IGroup 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 IIGroup 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 IIIGroup 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 IVGroup 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 VGroup 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Day 1.

Secondary outcomes (3)
  1. Respiratory Muscle Strength

    Respiratory muscles are composed of diaphragm, intercostal (internal and external), scalene, sternocleidomastoid, triangularis sterni, abdominal, shoulder and neck muscles. Respiratory muscle strength can be measured in many different ways. The maximum inspiratory and expiratory pressures among the respiratory function tests are the measurements that are frequently used to evaluate the strength of the respiratory muscles. These measurements are directly related to respiratory muscle strengths and assist in determining the rehabilitation and exercise program by providing information about the patient's condition. Respiratory muscle strength measurements will be carried out in accordance with the standardization of the guidelines prepared by the American Thoracic Society (ATS) and the European Respiratory Society (ERS).

    Measured: Day 1.

  2. Measurement of Quality of Life

    Quality of life is accepted as a multidimensional structure with many different contents . In the measurement of quality of life; ''Nottingham Health Profile'' questionnaire will be used. Nottingham Health Profile is a questionnaire consisting of 7 subtitles and 45 questions including physical, social and psychological evaluations. This multifaceted scale includes: pain, emotional reactions, sleep, physical activity, energy and health status

    Measured: Day 1.

  3. Perception Of Exercise

    Aerobic exercise capacity is an essential component of physical fitness. Perceived benefits and perceived barriers to participating in physical activity will be assessed through the Exercise Benefits / Barriers Scale This scale consists of 43 multiple-choice questions. According to the answers given, the minimum score that can be taken is 43 and the maximum score is 172. The higher the score, the better the perception of people about exercise..

    Measured: Day 1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start1 Mar 2020
  3. Primary completion24 Dec 2021
  4. Study completion24 Dec 2021

Resources

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
Case-control
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04780828
Sponsor's protocol ID
10840098-772.02-E.61593
Status last verified
Feb 2022
First submitted
23 Feb 2021
Last updated
15 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States, 2009-2010. NCHS Data Brief. 2012 Jan;(82):1-8.

    PubMed 22617494
  • Forhan M. An analysis of disability models and the application of the ICF to obesity. Disabil Rehabil. 2009;31(16):1382-8. doi: 10.1080/09638280802572981.

    PubMed 19340616
  • Sirtori A, Brunani A, Villa V, Berselli ME, Croci M, Leonardi M, Raggi A. Obesity is a marker of reduction in QoL and disability. ScientificWorldJournal. 2012;2012:167520. doi: 10.1100/2012/167520. Epub 2012 Mar 12.

    PubMed 22536122
  • Vranesic Bender D, Krznaric Z. Nutritional and behavioral modification therapies of obesity: facts and fiction. Dig Dis. 2012;30(2):163-7. doi: 10.1159/000336670. Epub 2012 Jun 20.

    PubMed 22722432
  • Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.

    PubMed 30814686
  • The Lancet Public Health. Tackling obesity seriously: the time has come. Lancet Public Health. 2018 Apr;3(4):e153. doi: 10.1016/S2468-2667(18)30053-7. No abstract available.

    PubMed 29627076
  • Bray GA. Risks of obesity. Endocrinol Metab Clin North Am. 2003 Dec;32(4):787-804, viii. doi: 10.1016/s0889-8529(03)00067-7.

    PubMed 14711062
  • Laskowski ER. Action on obesity and fitness: the physiatrist's role. PM R. 2009 Sep;1(9):795-7. doi: 10.1016/j.pmrj.2009.08.448. No abstract available.

    PubMed 19769911
  • Raggi A, Sirtori A, Brunani A, Liuzzi A, Leonardi M. Use of the ICF to describe functioning and disability in obese patients. Disabil Rehabil. 2009;31 Suppl 1:S153-8. doi: 10.3109/09638280903317724.

    PubMed 19968528
  • Dixon AE, Peters U. The effect of obesity on lung function. Expert Rev Respir Med. 2018 Sep;12(9):755-767. doi: 10.1080/17476348.2018.1506331. Epub 2018 Aug 14.

    PubMed 30056777
  • Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.

    PubMed 31613151
  • Wen AS, Woo MS, Keens TG. How many maneuvers are required to measure maximal inspiratory pressure accurately. Chest. 1997 Mar;111(3):802-7. doi: 10.1378/chest.111.3.802.

    PubMed 9118723
  • American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.

    PubMed 12186831
  • Chiu HY, Chen PY, Chuang LP, Chen NH, Tu YK, Hsieh YJ, Wang YC, Guilleminault C. Diagnostic accuracy of the Berlin questionnaire, STOP-BANG, STOP, and Epworth sleepiness scale in detecting obstructive sleep apnea: A bivariate meta-analysis. Sleep Med Rev. 2017 Dec;36:57-70. doi: 10.1016/j.smrv.2016.10.004. Epub 2016 Nov 5.

    PubMed 27919588
  • Onat A, Hergenc G, Yuksel H, Can G, Ayhan E, Kaya Z, Dursunoglu D. Neck circumference as a measure of central obesity: associations with metabolic syndrome and obstructive sleep apnea syndrome beyond waist circumference. Clin Nutr. 2009 Feb;28(1):46-51. doi: 10.1016/j.clnu.2008.10.006. Epub 2008 Nov 17.

    PubMed 19010573

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Adolescent and Obesity, Morbid, run by Istanbul Medipol University Hospital 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 15 Feb 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Function Parameters (time frame: Day 1.). 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 NCT04780828, which also lists 36 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 15 Feb 2022.

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