Muscle Function, Handgrip Strength TestFUBANCT02811393
Muscle Assessment in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery
An observational study of Muscle Function, Handgrip Strength Test, run by University of Chile at 1 site in Chile.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Function, Handgrip Strength Test
- What is being tested?
- Assess muscle function
- How many people
- 26 participants
- Where
- 1 siteChile
- Study dates
- Jun 2016to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Case group: women, 18-70 y, submitted to a Roux-en-Y Gastric Bypass Surgery at least two years ago
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Muscle Function Test in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery
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
Read the detailed 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.
- Conditions
- Muscle Function, Handgrip Strength Test
- Being tested
- Assess muscle function
- Keywords
- Bariatric surgery, sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess muscle functionOther
Assess muscle function with hand grip test and sit and stand test
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Women who have been submitted to a Roux-en-Y Gastric Bypass Surgery for at least 2 years Receives: 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 Receives: Other: Assess muscle function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength
Assess handgrip test with a "Jamar®" hydraulic hand dynamometer
Measured: One time (initial assesment)
Secondary outcomes (2)
Sit and stand
Number of repetitions of sit ups within 30 seconds
Measured: One time (initial assesment)
Physical Activity Level
Assessment with International Physical Activity Questionnaires (IPAQ)
Measured: One time (initial assesment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Muscle Function, Handgrip Strength TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Chilena de Nutrición Clínica, Obesidad y Metabolismo
- Responsible party
- Principal investigator, Pamela Rojas, University of Chile
- Investigators
- Andres F Sanchez, MD, MSc, Principal investigator, University of ChilePamela A Rojas, MD, MSc, Study director, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811393
- Sponsor's protocol ID
- ACHINUMET1
- Acronym
- FUBA
- Status last verified
- Mar 2019
- First submitted
- 21 Jun 2016
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 15616203Chaston 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.
PubMed 17075583Prado 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.
PubMed 26743210Gasteyger 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.
PubMed 16545153Carrasco 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.
PubMed 17658019Carrasco 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.
PubMed 18683014Vaurs 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.
PubMed 26022386Moize 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.
PubMed 23200926Ceglia 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.
PubMed 22968766Aleman-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.
PubMed 24325896Norman 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.
PubMed 21035927Bohannon 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.
PubMed 25598584
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Muscle Function Test in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT02811393
- Acronym / sponsor ID
- FUBA / ACHINUMET1
- Conditions
- Muscle Function, Handgrip Strength Test
- Keywords
- Bariatric surgery, sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Asociación Chilena de Nutrición Clínica, Obesidad y Metabolismo
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | – | Other: Assess muscle functionWomen who have been submitted to a Roux-en-Y Gastric Bypass Surgery for at least 2 years |
| Unoperated | – | Other: Assess muscle functionWomen with similar characteristics to control group (age, body mass index, physical activity level), but they have not been submitted to bariatric surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Case group: women, 18-70 y, submitted to a Roux-en-Y Gastric Bypass Surgery at least two years ago
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assess muscle functionAssess muscle function with hand grip test and sit and stand test | Other | Bariatric surgery, Unoperated |
Primary outcome
Handgrip strength
Time frame: One time (initial assesment)
Assess handgrip test with a "Jamar®" hydraulic hand dynamometer
2 secondary outcomes
Sit and stand
Time frame: One time (initial assesment)
Physical Activity Level
Time frame: One time (initial assesment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Results publication: PubMed 15616203Sjostrom 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.
- Results publication: PubMed 17075583Chaston 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.
- Results publication: PubMed 26743210Prado 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.
- Results publication: PubMed 16545153Gasteyger 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.
- Results publication: PubMed 17658019Carrasco 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.
- Results publication: PubMed 18683014Carrasco 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.
- Results publication: PubMed 26022386Vaurs 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.
- Results publication: PubMed 23200926Moize 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.
- Results publication: PubMed 22968766Ceglia 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.
- Results publication: PubMed 24325896Aleman-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.
- Results publication: PubMed 21035927Norman 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.
- Results publication: PubMed 25598584Bohannon 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.
- Individual participant dataSharing planned: No
Related trials for Muscle Function, Handgrip Strength Test
Active, not recruitingPhase 1
Aging Resilience Through Microbiota Optimization and Regulation
Resilience, Cognitive Function and Well-Being
Not yet recruiting
Effects of Policosanol and Exercise on Fitness and Lipids in People With Elevated Blood Lipids
Dyslipidemia, Elevated Blood Lipids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres F Sanchez, MD, MSc principal investigator
University of Chile
Pamela A Rojas, MD, MSc study director
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Function, Handgrip Strength Test, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip strength (time frame: One time (initial assesment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02811393, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.