Clinical trial NCT02811393: Muscle Assessment in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery
Official title: Assessment of the Muscle Function Test in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Function, Handgrip Strength Test
Keywords: Bariatric surgery, sarcopenia
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Asociación Chilena de Nutrición Clínica, Obesidad y Metabolismo
First posted: 2016-06-23
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Handgrip strength
timeFrame: One time (initial assesment)
Secondary outcomes:
measure: Sit and stand
timeFrame: One time (initial assesment)
measure: Physical Activity Level
timeFrame: One time (initial assesment)
Other outcomes:
measure: Nutritional status of some vitamins and minerals
timeFrame: One time (initial assesment)
measure: Body composition
timeFrame: One time (initial assesment)
Locations:
city: Santiago
country: Chile
facility: University of Chile
state: Metropolitana
Study officials:
affiliation: University of Chile
name: Andres F Sanchez, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Pamela A Rojas, MD, MSc
role: STUDY_DIRECTOR
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