Muscle Assessment in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery

Muscle Function, Handgrip Strength Test Clinical Trial

— FUBA  

Official title:

Assessment of the Muscle Function Test in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811393
• Other study ID #: ACHINUMET1
• Status: Completed
• Start date: June 2016
• Est. completion date: January 2019

Study information

• Verified date: March 2019
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess muscle function in women at least two years after being submitted to Roux-en-Y Gastric Bypass Surgery and compare with a control group

Description:

Obesity is a public health problem globally. According to the World Health Organization (WHO) estimated are 600 million obese worldwide and according to National Health Survey 2010 in Chile 67% of the population suffers from some degree of overweight having approximately 300,000 morbidly obese.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Case group: women, 18-70 y, submitted to a Roux-en-Y Gastric Bypass Surgery at least two years ago

Exclusion Criteria:

• osteoarthritis of hands and knees, any osteoarticular, rheumatologic or neurological disease hindering the performance of the tests of muscle function; type 2 diabetes mellitus; acute infectious diseases; use of muscle relaxants; physical and intellectual disabilities and uncontrolled hypothyroidism.

Related Conditions & MeSH terms

• Muscle Function, Handgrip Strength Test

Intervention

Other:
• Assess muscle function
Assess muscle function with hand grip test and sit and stand test

Locations

Country	Name	City	State
Chile	University of Chile	Santiago	Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Asociación Chilena de Nutrición Clínica, Obesidad y Metabolismo

Country where clinical trial is conducted

Chile, 

References & Publications (12)

Alemán-Mateo H, López Teros MT, Ramírez FA, Astiazarán-García 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 B — View Citation

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. — View Citation

Carrasco F, Papapietro K, Csendes A, Salazar G, Echenique C, Lisboa C, Díaz 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. Erratum in: Obes Sur — View Citation

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 surg — View Citation

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. Review. — View Citation

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. Epub 2006 Oct 31. Review. — View Citation

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. — View Citation

Moizé V, Andreu A, Rodríguez L, Flores L, Ibarzabal A, Lacy A, Jiménez 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. — View Citation

Norman K, Stobäus 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. Review. — View Citation

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. Review. — View Citation

Sjöström L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjöström CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after — View Citation

Vaurs C, Diméglio 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nutritional status of some vitamins and minerals	Some vitamins and minerals related to muscle function will be measured in plasma or serum.	One time (initial assesment)
Other	Body composition	Fat free mass is determined with a whole body Dual-energy X-ray Absorptiometry (DXA) scan	One time (initial assesment)
Primary	Handgrip strength	Assess handgrip test with a "Jamar®" hydraulic hand dynamometer	One time (initial assesment)
Secondary	Sit and stand	Number of repetitions of sit ups within 30 seconds	One time (initial assesment)
Secondary	Physical Activity Level	Assessment with International Physical Activity Questionnaires (IPAQ)	One time (initial assesment)

External Links

•   National Survey Chile