An observational study in Muscle Function, Handgrip Strength Test, sponsored by University of Chile. Completed at 1 site in Chile. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-06.
Sponsored by University of Chile · Observational
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
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.
University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Case group: women, 18-70 y, submitted to a Roux-en-Y Gastric Bypass Surgery at least two years ago
Exclusion Criteria:
Women who have been submitted to a Roux-en-Y Gastric Bypass Surgery for at least 2 years
Other: Assess muscle function
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
Assess muscle function with hand grip test and sit and stand test
Handgrip strength
Assess handgrip test with a "Jamar®" hydraulic hand dynamometer
Time frame: One time (initial assesment)
Sit and stand
Number of repetitions of sit ups within 30 seconds
Time frame: One time (initial assesment)
Physical Activity Level
Assessment with International Physical Activity Questionnaires (IPAQ)
Time frame: One time (initial assesment)
Nutritional status of some vitamins and minerals
Some vitamins and minerals related to muscle function will be measured in plasma or serum.
Time frame: One time (initial assesment)
Body composition
Fat free mass is determined with a whole body Dual-energy X-ray Absorptiometry (DXA) scan
Time frame: One time (initial assesment)
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Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University of Chile