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Completed

NCT Number: NCT02811393

Muscle Assessment 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

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Chile

Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assess muscle function

Other

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

Primary outcomes

  1. Handgrip strength

    Time frame: One time (initial assesment)

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

Secondary outcomes

  1. Sit and stand

    Time frame: One time (initial assesment)

    Number of repetitions of sit ups within 30 seconds

  2. Physical Activity Level

    Time frame: One time (initial assesment)

    Assessment with International Physical Activity Questionnaires (IPAQ)

Other outcomes

  1. Nutritional status of some vitamins and minerals

    Time frame: One time (initial assesment)

    Some vitamins and minerals related to muscle function will be measured in plasma or serum.

  2. Body composition

    Time frame: One time (initial assesment)

    Fat free mass is determined with a whole body Dual-energy X-ray Absorptiometry (DXA) scan

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Asociación Chilena de Nutrición Clínica, Obesidad y Metabolismo

Registry information

Official study title

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

Acronym: FUBA

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jun 23, 2016
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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