Obesity Clinical Trial
— SarxObOfficial title:
Research of Sarcopenia in Patients After Bariatric-metabolic Surgery - the Effect of Programmed Aerobic and Power Exercising on the Functionality, Volume and Morphology of Muscle Tissue
The investigators' study published in 2020 (Pekar, M. et al.: The risk of sarcopenia 24 months after bariatric surgery - assessment by dual energy X-ray absorptiometry (DEXA): a prospective study; Videosurgery Miniinv 2020; https://doi.org/10.5114/wiitm.2020.93463) shows that patients are at risk of sar-copenia after bariatric-metabolic (BM) surgery. BM surgery leads to significant changes in body composition. Significant fat loss is followed by unwanted muscle loss. The study shows that the lack of physical activity is typical for these patients. To the algorithm of postoperative care the investigators plan to include controlled exercise programs for these patients. The investigators do not know what the complexity and time required to keep patients in good condition and reduce the risk of sarcopenia is. The investigators want to find the adequate amount of physical activity while maintaining long-term compliance of these patients.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Body mass index 30-50 kg/m2 - ability to understand informed consent - signed informed consent - patient's residence within 100 km from Ostrava Czech Republic Exclusion Criteria: - History of gastric surgery - acute gastric ulcers or inflammation - Type 1 Diabetes mellitus - celiac disease - history of malignity - previous bariatric-metabolic surgery or endoscopic obesity treatment, - specific genetic and humoral diseases connected to obesity (Prader-Willi syndrome, mutation of melanocortin receptor 4, etc.) - history of knee surgery - non MRI compatible patients' devices and implants - severe hematological diseases - acute or chronic pancreatitis - cirrhosis - severe psychiatric diseases - uncontrolled hypertense - immunological diseases - long-term corticoid therapy - uncontrolled thyroid diseases - renal insufficiency - alcohol abuse |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Masaryk University | Hospital AGEL Ostrava-Vitkovice, University of Ostrava |
Beaudart C, Dawson A, Shaw SC, Harvey NC, Kanis JA, Binkley N, Reginster JY, Chapurlat R, Chan DC, Bruyère O, Rizzoli R, Cooper C, Dennison EM; IOF-ESCEO Sarcopenia Working Group. Nutrition and physical activity in the prevention and treatment of sarcopenia: systematic review. Osteoporos Int. 2017 Jun;28(6):1817-1833. doi: 10.1007/s00198-017-3980-9. Epub 2017 Mar 1. Review. — View Citation
Bosaeus I, Rothenberg E. Nutrition and physical activity for the prevention and treatment of age-related sarcopenia. Proc Nutr Soc. 2016 May;75(2):174-80. doi: 10.1017/S002966511500422X. Epub 2015 Dec 1. Review. — View Citation
CARSOTE, Mara, Razvan PETRESCU, Adriana Elena NICA, Adina GHEMIGIAN, Dan Nicolae PADURARU a Ana VALEA. BARIATRIC SURGERY AND OSTEOPO-ROSIS. Romanian Medical Journal [online]. 2016, 63(4), 297-299 [cit. 2020-10-12]. ISSN 12205478.
CARVALHO, Nara, Caio LIMEIRA, Vinícius BACCIN, et al. SAT-LB018 Different Definitions of Sarcopenia and Its Correlations with Anthropometric Measure-ments, Body Composition, Handgrip Strength, Metabolic Profile and Bone Mine-ral Density in Obese Women. Journal of the Endocrine Society [online]. 2019, 3
CARVALHO, Nara, Vinícius BACCIN, Narriane HOLANDA, João FILHO, Marta CA-RVALHO, Gitana SILVA, Flávia PIMENTA a José ALVES. SUN-542 Comparison of Different Muscle Mass Indices for Evaluation of Low Muscle Mass Regarding Muscle Function, Bone Mineral Density and Metabolic Profile in Obese Patients Prior to Bariatric Surgery. Journal of the Endocrine Society [online]. 2019, 3 [cit. 2020-10-12]. ISSN 24721972.
Ciudin A, Simó-Servat A, Palmas F, Barahona MJ. Sarcopenic obesity: a new challenge in the practical clinic. Endocrinol Diabetes Nutr. 2020 Jun 18. pii: S2530-0164(20)30103-8. doi: 10.1016/j.endinu.2020.03.004. [Epub ahead of print] Review. English, Spanish. — View Citation
Dantas WS, Roschel H, Murai IH, Gil S, Davuluri G, Axelrod CL, Ghosh S, Newman SS, Zhang H, Shinjo SK, das Neves W, Merege-Filho C, Teodoro WR, Capelozzi VL, Pereira RM, Benatti FB, de Sá-Pinto AL, de Cleva R, Santo MA, Kirwan JP, Gualano B. Exercise-Induced Increases in Insulin Sensitivity After Bariatric Surgery Are Mediated By Muscle Extracellular Matrix Remodeling. Diabetes. 2020 Aug;69(8):1675-1691. doi: 10.2337/db19-1180. Epub 2020 May 14. — View Citation
Delgado André L, Basso-Vanelli RP, Di Thommazo-Luporini L, Angélica Ricci P, Cabiddu R, Pilon Jürgensen S, Ricardo de Oliveira C, Arena R, Borghi-Silva A. Functional and systemic effects of whole body electrical stimulation post bariatric surgery: study protocol for a randomized controlled trial. Trials. 2018 Oct 31;19(1):597. doi: 10.1186/s13063-018-2844-8. — View Citation
Esposito A, Campana L, Palmisano A, De Cobelli F, Canu T, Santarella F, Colantoni C, Monno A, Vezzoli M, Pezzetti G, Manfredi AA, Rovere-Querini P, Del Maschio A. Magnetic resonance imaging at 7T reveals common events in age-related sarcopenia and in the homeostatic response to muscle sterile injury. PLoS One. 2013;8(3):e59308. doi: 10.1371/journal.pone.0059308. Epub 2013 Mar 12. — View Citation
Gray C, MacGillivray TJ, Eeley C, Stephens NA, Beggs I, Fearon KC, Greig CA. Magnetic resonance imaging with k-means clustering objectively measures whole muscle volume compartments in sarcopenia/cancer cachexia. Clin Nutr. 2011 Feb;30(1):106-11. doi: 10.1016/j.clnu.2010.07.012. Epub 2010 Aug 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes of lean mass by DXA measures (in kg/m2) | higher values mean better result | 24 months | |
Primary | fat infiltration of muscles by MRI (in %) | lower content of fat means better result | 24 months | |
Primary | muscle strength by handgrip dynamometer (in kg) | higher values in this physical performance test mean better result | 24 months | |
Primary | muscle strength by walk test (in m) | higher values in this physical performance test mean better result | 24 months | |
Primary | muscle strength by Timed Up and Go test (in s) | lower values in this physical performance test mean better result | 24 months | |
Primary | thickness of cartilage surface of the knee by MRI (in mm) | higher values mean better result | 24 months | |
Secondary | changes of fat mass by DXA measures (in kg/m2) | lower values mean better result | 24 months |
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