Muscle Assessment in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery
NCT ID: NCT02811393
Last Updated: 2019-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26 participants
OBSERVATIONAL
2016-06-30
2019-01-31
Brief Summary
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Detailed Description
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The first-line treatment for obesity is diet, exercise and cognitive behavioral therapy, however, these interventions are not effective enough to control long-term obesity, and so bariatric surgery is currently the treatment of choice to control morbid obesity.
Overall, after bariatric surgery, most patients lose on average 60% of excess weight and improve their comorbidities during the first postoperative year, however, the long term effects of this weight reduction are not known in detail regarding body composition and muscle function.
The aim of this study is to assess muscle function measured by hand grip strength test in women at least 2 years after bariatric surgery (Roux-en-Y Gastric Bypass) and to compare with control group.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Bariatric surgery
Women who have been submitted to a Roux-en-Y Gastric Bypass Surgery for at least 2 years
Assess muscle function
Assess muscle function with hand grip test and sit and stand test
Unoperated
Women with similar characteristics to control group (age, body mass index, physical activity level), but they have not been submitted to bariatric surgery
Assess muscle function
Assess muscle function with hand grip test and sit and stand test
Interventions
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Assess muscle function
Assess muscle function with hand grip test and sit and stand test
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
FEMALE
Yes
Sponsors
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Asociación Chilena de Nutrición Clínica, Obesidad y Metabolismo
UNKNOWN
University of Chile
OTHER
Responsible Party
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Pamela Rojas
Assistant professor
Principal Investigators
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Andres F Sanchez, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Chile
Pamela A Rojas, MD, MSc
Role: STUDY_DIRECTOR
University of Chile
Locations
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University of Chile
Santiago, Santiago Metropolitan, Chile
Countries
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References
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Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
Chaston TB, Dixon JB, O'Brien PE. Changes in fat-free mass during significant weight loss: a systematic review. Int J Obes (Lond). 2007 May;31(5):743-50. doi: 10.1038/sj.ijo.0803483. Epub 2006 Oct 31.
Prado CM, Cushen SJ, Orsso CE, Ryan AM. Sarcopenia and cachexia in the era of obesity: clinical and nutritional impact. Proc Nutr Soc. 2016 May;75(2):188-98. doi: 10.1017/S0029665115004279. Epub 2016 Jan 8.
Gasteyger C, Suter M, Calmes JM, Gaillard RC, Giusti V. Changes in body composition, metabolic profile and nutritional status 24 months after gastric banding. Obes Surg. 2006 Mar;16(3):243-50. doi: 10.1381/096089206776116381.
Carrasco F, Papapietro K, Csendes A, Salazar G, Echenique C, Lisboa C, Diaz E, Rojas J. Changes in resting energy expenditure and body composition after weight loss following Roux-en-Y gastric bypass. Obes Surg. 2007 May;17(5):608-16. doi: 10.1007/s11695-007-9117-z.
Carrasco F, Ruz M, Rojas P, Csendes A, Rebolledo A, Codoceo J, Inostroza J, Basfi-Fer K, Papapietro K, Rojas J, Pizarro F, Olivares M. Changes in bone mineral density, body composition and adiponectin levels in morbidly obese patients after bariatric surgery. Obes Surg. 2009 Jan;19(1):41-6. doi: 10.1007/s11695-008-9638-0. Epub 2008 Aug 6.
Vaurs C, Dimeglio C, Charras L, Anduze Y, Chalret du Rieu M, Ritz P. Determinants of changes in muscle mass after bariatric surgery. Diabetes Metab. 2015 Nov;41(5):416-21. doi: 10.1016/j.diabet.2015.04.003. Epub 2015 May 26.
Moize V, Andreu A, Rodriguez L, Flores L, Ibarzabal A, Lacy A, Jimenez A, Vidal J. Protein intake and lean tissue mass retention following bariatric surgery. Clin Nutr. 2013 Aug;32(4):550-5. doi: 10.1016/j.clnu.2012.11.007. Epub 2012 Nov 14.
Ceglia L, Harris SS. Vitamin D and its role in skeletal muscle. Calcif Tissue Int. 2013 Feb;92(2):151-62. doi: 10.1007/s00223-012-9645-y. Epub 2012 Sep 12.
Aleman-Mateo H, Lopez Teros MT, Ramirez FA, Astiazaran-Garcia H. Association between insulin resistance and low relative appendicular skeletal muscle mass: evidence from a cohort study in community-dwelling older men and women participants. J Gerontol A Biol Sci Med Sci. 2014 Jul;69(7):871-7. doi: 10.1093/gerona/glt193. Epub 2013 Dec 10.
Norman K, Stobaus N, Gonzalez MC, Schulzke JD, Pirlich M. Hand grip strength: outcome predictor and marker of nutritional status. Clin Nutr. 2011 Apr;30(2):135-42. doi: 10.1016/j.clnu.2010.09.010. Epub 2010 Oct 30.
Bohannon RW, Bubela DJ, Magasi SR, Wang YC, Gershon RC. Sit-to-stand test: Performance and determinants across the age-span. Isokinet Exerc Sci. 2010;18(4):235-240. doi: 10.3233/IES-2010-0389.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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ACHINUMET1
Identifier Type: -
Identifier Source: org_study_id
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