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

NCT02811393 | Completed

• 1 other identifier: ACHINUMET1
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Muscle Function, Handgrip Strength Test

Keywords

Bariatric surgery, sarcopenia

Outcome Measures

Primary Outcomes (1)

• Handgrip strength

  Assess handgrip test with a "Jamar®" hydraulic hand dynamometer

  One time (initial assesment)

Secondary Outcomes (2)

• Sit and stand

  One time (initial assesment)

• Physical Activity Level

  One time (initial assesment)

Other Outcomes (2)

• Nutritional status of some vitamins and minerals

  One time (initial assesment)

• Body composition

  One time (initial assesment)

Study Arms (2)

Bariatric surgery

Women who have been submitted to a Roux-en-Y Gastric Bypass Surgery for at least 2 years

Other: Assess muscle function

Unoperated

Women with similar characteristics to control group (age, body mass index, physical activity level), but they have not been submitted to bariatric surgery

Other: Assess muscle function

Interventions

Assess muscle function OTHER

Assess muscle function with hand grip test and sit and stand test

Bariatric surgery; Unoperated

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two groups of study subjects: bariatric surgery group (case group) and nonoperated group (control group) The case group will be composed of women that were operated two or more years ago of Roux-en-Y Gastric Bypass Surgery, with a 50% or less weight regain. The control group will be composed of subjects with no history of bariatric surgery and match with the surgical group by gender, age, body mass index (BMI) and physical activity Control group will be selected form people who work or study in Faculty of Medicine, University of Chile and case group will be selected from former patients evaluated at Nutrition Department of the University of Chile.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead
• Asociación Chilena de Nutrición Clínica, Obesidad y Metabolismo: collaborator

Study Sites (1)

University of Chile

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (12)

• 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.

  PMID: 15616203 RESULT

• 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.

  PMID: 17075583 RESULT

• 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.

  PMID: 26743210 RESULT

• 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.

  PMID: 16545153 RESULT

• 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.

  PMID: 17658019 RESULT

• 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.

  PMID: 18683014 RESULT

• 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.

  PMID: 26022386 RESULT

• 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.

  PMID: 23200926 RESULT

• 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.

  PMID: 22968766 RESULT

• 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.

  PMID: 24325896 RESULT

• 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.

  PMID: 21035927 RESULT

• 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.

  PMID: 25598584 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, urine.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Andres F Sanchez, MD, MSc

  University of Chile

  PRINCIPAL INVESTIGATOR

• Pamela A Rojas, MD, MSc

  University of Chile

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 23, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)