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

NCT04780828 | Completed DMC

• 1 other identifier: 10840098-772.02-E.61593
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity, Adolescent; Obesity, Morbid; Obesity, Abdominal; Obesity, Visceral; Weight, Body

Keywords

Obesity; Respiratory System; Quality of Life; Anthropometric Measurements; Body Composition

Outcome Measures

Primary Outcomes (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).

  Day 1.

Secondary Outcomes (3)

• Respiratory Muscle Strength

  Day 1.

• Measurement of Quality of Life

  Day 1.

• Perception Of Exercise

  Day 1.

Other Outcomes (16)

• Anthropometric Measurements Ratios

  Day 1.

• Neck Circumference

  Day 1.

• Waist Circumference

  Day 1.

Study Arms (5)

GROUP I

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

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

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

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

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Medipol University: collaborator

Study Sites (1)

Istanbul University-Cerrahpaşa Faculty of Medicine Internal Medicine Department of Endocrinology and Metabolic Diseases

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (36)

• 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.

  PMID: 22617494 BACKGROUND

• 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.

  PMID: 19340616 BACKGROUND

• 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.

  PMID: 22536122 BACKGROUND

• 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.

  PMID: 22722432 BACKGROUND

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

  PMID: 30814686 BACKGROUND

• 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.

  PMID: 29627076 BACKGROUND

• 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.

  PMID: 14711062 BACKGROUND

• 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.

  PMID: 19769911 BACKGROUND

• 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.

  PMID: 19968528 BACKGROUND

• 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.

  PMID: 30056777 BACKGROUND

• 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.

  PMID: 31613151 BACKGROUND

• 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.

  PMID: 9118723 BACKGROUND

• 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.

  PMID: 12186831 BACKGROUND

• 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.

  PMID: 27919588 BACKGROUND

• 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.

  PMID: 19010573 BACKGROUND

• Ahbab S, Ataoglu HE, Tuna M, Karasulu L, Cetin F, Temiz LU, Yenigun M. Neck circumference, metabolic syndrome and obstructive sleep apnea syndrome; evaluation of possible linkage. Med Sci Monit. 2013 Feb 13;19:111-7. doi: 10.12659/MSM.883776.

  PMID: 23403781 BACKGROUND

• van Vugt JL, Cakir H, Kornmann VN, Doodeman HJ, Stoot JH, Boerma D, Houdijk AP, Hulsewe KW. The new Body Mass Index as a predictor of postoperative complications in elective colorectal cancer surgery. Clin Nutr. 2015 Aug;34(4):700-4. doi: 10.1016/j.clnu.2014.08.006. Epub 2014 Aug 15.

  PMID: 25171837 BACKGROUND

• Gomez-Ambrosi J, Silva C, Catalan V, Rodriguez A, Galofre JC, Escalada J, Valenti V, Rotellar F, Romero S, Ramirez B, Salvador J, Fruhbeck G. Clinical usefulness of a new equation for estimating body fat. Diabetes Care. 2012 Feb;35(2):383-8. doi: 10.2337/dc11-1334. Epub 2011 Dec 16.

  PMID: 22179957 BACKGROUND

• Bergman RN, Stefanovski D, Buchanan TA, Sumner AE, Reynolds JC, Sebring NG, Xiang AH, Watanabe RM. A better index of body adiposity. Obesity (Silver Spring). 2011 May;19(5):1083-9. doi: 10.1038/oby.2011.38. Epub 2011 Mar 3.

  PMID: 21372804 BACKGROUND

• Krakauer NY, Krakauer JC. A new body shape index predicts mortality hazard independently of body mass index. PLoS One. 2012;7(7):e39504. doi: 10.1371/journal.pone.0039504. Epub 2012 Jul 18.

  PMID: 22815707 BACKGROUND

• Faria SL, Faria OP, Cardeal MD, Ito MK. Validation study of multi-frequency bioelectrical impedance with dual-energy X-ray absorptiometry among obese patients. Obes Surg. 2014 Sep;24(9):1476-80. doi: 10.1007/s11695-014-1190-5.

  PMID: 24464546 BACKGROUND

• Sarwer DB, Steffen KJ. Quality of Life, Body Image and Sexual Functioning in Bariatric Surgery Patients. Eur Eat Disord Rev. 2015 Nov;23(6):504-8. doi: 10.1002/erv.2412.

  PMID: 26608946 BACKGROUND

• Niero M, Martin M, Finger T, Lucas R, Mear I, Wild D, Glauda L, Patrick DL. A new approach to multicultural item generation in the development of two obesity-specific measures: the Obesity and Weight Loss Quality of Life (OWLQOL) questionnaire and the Weight-Related Symptom Measure (WRSM). Clin Ther. 2002 Apr;24(4):690-700. doi: 10.1016/s0149-2918(02)85144-x.

  PMID: 12017412 BACKGROUND

• Myers A, Rosen JC. Obesity stigmatization and coping: relation to mental health symptoms, body image, and self-esteem. Int J Obes Relat Metab Disord. 1999 Mar;23(3):221-30. doi: 10.1038/sj.ijo.0800765.

  PMID: 10193866 BACKGROUND

• Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.

  PMID: 10826123 BACKGROUND

• Oppert JM, Bellicha A, Roda C, Bouillot JL, Torcivia A, Clement K, Poitou C, Ciangura C. Resistance Training and Protein Supplementation Increase Strength After Bariatric Surgery: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Nov;26(11):1709-1720. doi: 10.1002/oby.22317.

  PMID: 30358153 BACKGROUND

• Spruit MA, Sillen MJ, Groenen MT, Wouters EF, Franssen FM. New normative values for handgrip strength: results from the UK Biobank. J Am Med Dir Assoc. 2013 Oct;14(10):775.e5-11. doi: 10.1016/j.jamda.2013.06.013. Epub 2013 Aug 16.

  PMID: 23958225 BACKGROUND

• Baillot A, Vallee CA, Mampuya WM, Dionne IJ, Comeau E, Meziat-Burdin A, Langlois MF. Effects of a Pre-surgery Supervised Exercise Training 1 Year After Bariatric Surgery: a Randomized Controlled Study. Obes Surg. 2018 Apr;28(4):955-962. doi: 10.1007/s11695-017-2943-8.

  PMID: 28963710 BACKGROUND

• Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.

  PMID: 24787074 BACKGROUND

• Bohannon RW, Crouch RH. Two-Minute Step Test of Exercise Capacity: Systematic Review of Procedures, Performance, and Clinimetric Properties. J Geriatr Phys Ther. 2019 Apr/Jun;42(2):105-112. doi: 10.1519/JPT.0000000000000164.

  PMID: 29210933 BACKGROUND

• Mesarwi O, Polak J, Jun J, Polotsky VY. Sleep disorders and the development of insulin resistance and obesity. Endocrinol Metab Clin North Am. 2013 Sep;42(3):617-34. doi: 10.1016/j.ecl.2013.05.001.

  PMID: 24011890 BACKGROUND

• Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

  PMID: 2803071 BACKGROUND

• Gils Contreras A, Bonada Sanjaume A, Montero Jaime M, Rabassa Soler A, Sabench Pereferrer F, Molina Lopez A, Becerra Tomas N, Del Castillo Dejardin D, Salas-Salvado J. Effects of Two Preoperatory Weight Loss Diets on Hepatic Volume, Metabolic Parameters, and Surgical Complications in Morbid Obese Bariatric Surgery Candidates: a Randomized Clinical Trial. Obes Surg. 2018 Dec;28(12):3756-3768. doi: 10.1007/s11695-018-3413-7.

  PMID: 30109669 BACKGROUND

• Sechrist KR, Walker SN, Pender NJ. Development and psychometric evaluation of the exercise benefits/barriers scale. Res Nurs Health. 1987 Dec;10(6):357-65. doi: 10.1002/nur.4770100603.

  PMID: 3423307 BACKGROUND

• FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.

  PMID: 13003946 BACKGROUND

• Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.

  PMID: 10377201 BACKGROUND

Related Links

• ''Waist Circumference and Waist to Hip Ratio: A Report of a WHO Expert Consultation''

MeSH Terms

Conditions

Pediatric Obesity; Obesity, Morbid; Obesity, Abdominal; Body Weight; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülay Aras Bayram, Phd

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 4, 2021
• Study Start: March 1, 2020
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

TU (1)