- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03119350
Mitochondrial Energy Metabolism in Obese Women
Mitochondrial Energy Metabolism in Obese Women Undergoing Concurrent Physical Training
Considering that the failure of the treatment of obesity is justified by the multifactorial pathophysiology of this morbidity, the present project has the following hypotheses:
- The occurrence of obesity is due to the derange,ent of mitochondrial energy metabolism ;
- The unbalance is therapeutically modified through physical training ;
- Obesity courses with the break-down in energy metabolism mitochondrial disease associated with systemic inflammatory characteristics that can be corrected through a combined long-term physical training program.
This study have as objective : to analyse changes in mitochondrial function, inflammatory profile, oxidative stress and energy metabolism caused by concurrent physical training in obese women.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Specific objectives:
Body composition by deuterium oxide; Metabolic rate of resting and oxidation of substrates by indirect calorimetry; Proinflammatory cytokines Anti-inflammatory cytokines Oxidative Stress: Malondialdehyde, Superoxide Dismutase, Glutathione-Peroxidase; Fatty acids: ceramide and palmitate; Mitochondrial respiration and citrate synthase enzyme; Quantify and qualify: mitochondrial number, endoplasmic reticulum structure, adipose cell size; Gene expression, quantify by microscopy and analyze the protein by western blot.
The study began with 20 women, however, there was withdrawal of 6, ending with 14 women.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
SP
-
Ribeirao Preto, SP, Brazylia, 14.048-900
- Camila Fernanda Cunha Brandão
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- This study included women with obesity (BMI of 30 to 40 kg / m²), sedentary, with no associated comorbidity, convenience sample
Exclusion Criteria:
- Women who have undergone bariatric surgery, menopause, cancer or any metabolic disease, smokers, alcoholics, who are in use of drugs that act directly on the metabolism and that have medical impediment to the practice of physical exercise.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Inny: Physical Training
There was concurrent physical training intervention: strength and aerobic exercises in the same session. Duration: 2 weeks of adaptation and learning to exercise, 8 weeks of physical training. Frequency: 3 times per week Duration: 55 minutes each session. Intensity: 75 to 90% of maximum heart rate. |
Intervention with concurrent physical training: strength and aerobic exercises in the same session. Duration: 2 weeks of adaptation to physical exercise, 8 weeks of training. Frequency: 3 times a week. Time: 55 minutes each session. Intensity: 75 to 90% of maximum heart rate. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Changes Body weight
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Body weight was measured by digital balance before and after the intervention
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes Body composition
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
The change in body composition through deuterium oxide was evaluated.
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes White adipose tissue biopsy
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
A subcutaneous tissue sample was collected for analysis of: mitochondrial respiration, citrate synthase enzyme, gene expression (UCP1, 2 and 3).
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes Indirect calorimetry
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
With a gas analyzer (indirect calorimeter), we evaluated the metabolic rate and rest (REE) and oxidation of substrates (Lipids and carbohydrates).
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes in fatty acids
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Collected in lithium heparin tubes, they were centrifuged.
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes oxidative stress
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Collected in lithium heparin tubes, they were centrifuged.
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes inflammatory cytokines
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Collected in lithium heparin tubes, they were centrifuged.
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes in total cholesterol
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Collected in lithium heparin tubes, they were centrifuged.
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes Physical Performance
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Based on the Shuttle Walking Test adaptation.
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes in Determination of Lactate
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Blood samples were collected by manual puncture of the earlobe in previously calibrated and heparinized capillary tubes, stored in eppendorf with sodium fluoride.
Analyzed by electrochemical lactate analyser.
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes Food intake
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Food registry of 3 days, the quantification of the daily intake of nutrients will still be made using software.
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes Nitrogen Balance
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Through the collection of urine of 24 hours the dosage of urinary nitrogen will be made by the chemiluminescence method for determination of protein nitrogen.
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Changes Telomere length
Ramy czasowe: Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
peripheral blood in ethylenediaminetetraacetic acid tubes and genomic DNA was automatically extracted from Peripheral Blood Mononuclear Cell.
The relative quantification of Telomere length was determined using the telomere to single copy gene ratio by Quantitative Polymerase Chain Reaction (qPCR).
|
Two times: (1) First day and (2) 10 weeks after adaptation and intervention
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.
- Frayn KN. Calculation of substrate oxidation rates in vivo from gaseous exchange. J Appl Physiol Respir Environ Exerc Physiol. 1983 Aug;55(2):628-34. doi: 10.1152/jappl.1983.55.2.628.
- WEIR JB. New methods for calculating metabolic rate with special reference to protein metabolism. J Physiol. 1949 Aug;109(1-2):1-9. doi: 10.1113/jphysiol.1949.sp004363. No abstract available.
- Burgomaster KA, Howarth KR, Phillips SM, Rakobowchuk M, Macdonald MJ, McGee SL, Gibala MJ. Similar metabolic adaptations during exercise after low volume sprint interval and traditional endurance training in humans. J Physiol. 2008 Jan 1;586(1):151-60. doi: 10.1113/jphysiol.2007.142109. Epub 2007 Nov 8.
- Heilbronn LK, Gan SK, Turner N, Campbell LV, Chisholm DJ. Markers of mitochondrial biogenesis and metabolism are lower in overweight and obese insulin-resistant subjects. J Clin Endocrinol Metab. 2007 Apr;92(4):1467-73. doi: 10.1210/jc.2006-2210. Epub 2007 Jan 23.
- Kraunsoe R, Boushel R, Hansen CN, Schjerling P, Qvortrup K, Stockel M, Mikines KJ, Dela F. Mitochondrial respiration in subcutaneous and visceral adipose tissue from patients with morbid obesity. J Physiol. 2010 Jun 15;588(Pt 12):2023-32. doi: 10.1113/jphysiol.2009.184754. Epub 2010 Apr 26. Erratum In: J Physiol. 2010 Oct 15; 588(Pt 20):4055.
- Yin X, Lanza IR, Swain JM, Sarr MG, Nair KS, Jensen MD. Adipocyte mitochondrial function is reduced in human obesity independent of fat cell size. J Clin Endocrinol Metab. 2014 Feb;99(2):E209-16. doi: 10.1210/jc.2013-3042. Epub 2013 Nov 25.
- Foster C. Monitoring training in athletes with reference to overtraining syndrome. Med Sci Sports Exerc. 1998 Jul;30(7):1164-8. doi: 10.1097/00005768-199807000-00023.
- Perry CG, Lally J, Holloway GP, Heigenhauser GJ, Bonen A, Spriet LL. Repeated transient mRNA bursts precede increases in transcriptional and mitochondrial proteins during training in human skeletal muscle. J Physiol. 2010 Dec 1;588(Pt 23):4795-810. doi: 10.1113/jphysiol.2010.199448. Epub 2010 Oct 4.
- BROWN, L.E.; WEIR, J.P.; ASEP procedures recommendation i: accurate assessment of muscular strength and power, Journal of Exercise Physiology, v. 4, n. 3, p. 1-21, 2001.
- Chomczynski P, Sacchi N. Single-step method of RNA isolation by acid guanidinium thiocyanate-phenol-chloroform extraction. Anal Biochem. 1987 Apr;162(1):156-9. doi: 10.1006/abio.1987.9999.
- Colégio Americano de Medicina Esportiva, CAME. Guia para Teste de Esforço e Prescrição de Exercício. 3º Edição, Medsi, Rio de janeiro, RJ, p.25, 1987.
- Crump C, Sundquist J, Winkleby MA, Sundquist K. Interactive effects of obesity and physical fitness on risk of ischemic heart disease. Int J Obes (Lond). 2017 Feb;41(2):255-261. doi: 10.1038/ijo.2016.209. Epub 2016 Nov 21.
- Curtis JM, Grimsrud PA, Wright WS, Xu X, Foncea RE, Graham DW, Brestoff JR, Wiczer BM, Ilkayeva O, Cianflone K, Muoio DE, Arriaga EA, Bernlohr DA. Downregulation of adipose glutathione S-transferase A4 leads to increased protein carbonylation, oxidative stress, and mitochondrial dysfunction. Diabetes. 2010 May;59(5):1132-42. doi: 10.2337/db09-1105. Epub 2010 Feb 11.
- Daussin FN, Zoll J, Dufour SP, Ponsot E, Lonsdorfer-Wolf E, Doutreleau S, Mettauer B, Piquard F, Geny B, Richard R. Effect of interval versus continuous training on cardiorespiratory and mitochondrial functions: relationship to aerobic performance improvements in sedentary subjects. Am J Physiol Regul Integr Comp Physiol. 2008 Jul;295(1):R264-72. doi: 10.1152/ajpregu.00875.2007. Epub 2008 Apr 16.
- EIGENTLER, A.; DRAXL, A.; et al. Laboratory Protocol: Citrate synthase a mitochondrial marker enzyme. Mitochondrial Physiology Network, v. 17.04, n. 3, p. 1-11, 2015.
- Fernstrom M, Bakkman L, Loogna P, Rooyackers O, Svensson M, Jakobsson T, Brandt L, Lagerros YT. Improved Muscle Mitochondrial Capacity Following Gastric Bypass Surgery in Obese Subjects. Obes Surg. 2016 Jul;26(7):1391-7. doi: 10.1007/s11695-015-1932-z.
- Ferreira FC, Bertucci DR, Barbosa MR, Nunes JE, Botero JP, Rodrigues MF, Shiguemoto GE, Santoro V, Verzola AC, Nonaka RO, Verzola RM, Baldissera V, Perez SE. Circuit resistance training in women with normal weight obesity syndrome: body composition, cardiometabolic and echocardiographic parameters, and cardiovascular and skeletal muscle fitness. J Sports Med Phys Fitness. 2017 Jul-Aug;57(7-8):1033-1044. doi: 10.23736/S0022-4707.16.06391-X. Epub 2016 Jul 6.
- FETT, C.A.; FETT, W.C.R.; MARCHINI, J.S. Fitness Level of Overweight/Obese Women After 08 Weeks of Aerobic or Mixed Metabolism Exercises. Revista Brasileira de Cineantropometria & Desempenho Humano, v. 11, p. 261-266, 2009.
- Grimble GK, West MF, Acuti AB, Rees RG, Hunjan MK, Webster JD, Frost PG, Silk DB. Assessment of an automated chemiluminescence nitrogen analyzer for routine use in clinical nutrition. JPEN J Parenter Enteral Nutr. 1988 Jan-Feb;12(1):100-6. doi: 10.1177/0148607188012001100.
- Koh EH, Park JY, Park HS, Jeon MJ, Ryu JW, Kim M, Kim SY, Kim MS, Kim SW, Park IS, Youn JH, Lee KU. Essential role of mitochondrial function in adiponectin synthesis in adipocytes. Diabetes. 2007 Dec;56(12):2973-81. doi: 10.2337/db07-0510. Epub 2007 Sep 7.
- Kong Z, Sun S, Liu M, Shi Q. Short-Term High-Intensity Interval Training on Body Composition and Blood Glucose in Overweight and Obese Young Women. J Diabetes Res. 2016;2016:4073618. doi: 10.1155/2016/4073618. Epub 2016 Sep 28.
- Lepage G, Roy CC. Improved recovery of fatty acid through direct transesterification without prior extraction or purification. J Lipid Res. 1984 Dec 1;25(12):1391-6.
- Medbo JI, Mamen A, Holt Olsen O, Evertsen F. Examination of four different instruments for measuring blood lactate concentration. Scand J Clin Lab Invest. 2000 Aug;60(5):367-80. doi: 10.1080/003655100750019279.
- Pfrimer K, Moriguti JC, Lima NK, Marchini JS, Ferriolli E. Bioelectrical impedance with different equations versus deuterium oxide dilution method for the inference of body composition in healthy older persons. J Nutr Health Aging. 2012 Feb;16(2):124-7. doi: 10.1007/s12603-011-0137-y.
- POLLOCK, M.L.; WILMORE, J.H.; FOX III, S.M. Exercícios na Saúde e na Doença - Avaliação e prescrição para prevenção e reabilitação. Rio de Janeiro: 1986.
- Tan S, Wang J, Cao L, Guo Z, Wang Y. Positive effect of exercise training at maximal fat oxidation intensity on body composition and lipid metabolism in overweight middle-aged women. Clin Physiol Funct Imaging. 2016 May;36(3):225-30. doi: 10.1111/cpf.12217. Epub 2014 Nov 19.
- Brandao CFC, Nonino CB, de Carvalho FG, Nicoletti CF, Noronha NY, San Martin R, de Freitas EC, Junqueira-Franco MVM, Marchini JS. The effects of short-term combined exercise training on telomere length in obese women: a prospective, interventional study. Sports Med Open. 2020 Jan 16;6(1):5. doi: 10.1186/s40798-020-0235-7.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Process HCRP: 1.387.040/2016
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Physical Training
-
Università degli Studi di SassariZakończonyStwardnienie rozsiane | Zmęczenie | SłabośćWłochy
-
Queen's UniversityZakończonySkuteczność Podręcznika zdrowienia jako narzędzia psychoedukacyjnego ułatwiającego powrót do zdrowiaZaburzenia psychiczneKanada
-
Beirut Arab UniversityZakończony
-
University of MiamiUnited States Department of DefenseRejestracja na zaproszenie
-
Oregon Health and Science UniversityUnited States Department of Defense; Colorado State University; Portland State...ZakończonySpać | Zachowanie zdrowotne | Dobre samopoczucieStany Zjednoczone
-
Diakonhjemmet HospitalThe Dam Foundation; The Norwegian Council for Musculoskeletal HealthRekrutacyjny
-
Centro Universitário Augusto MottaZakończonyBól | Ból pleców | Bóle krzyża | Manifestacje nerwowo-mięśniowe | Objawy i symptomyBrazylia
-
Ludwig-Maximilians - University of MunichPosit Science CorporationNieznany
-
Riphah International UniversityZakończony
-
Chang Gung Memorial HospitalRekrutacyjnyMałe Dzieci Z Niepełnosprawnościami MotorycznymiTajwan