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

Completed

• Conditions: Muscle Function, Handgrip Strength Test
• Interventions: Other: Assess muscle function

• Registration Number: NCT02811393
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-23
• Primary Completion: 2018-12
• Study Completion: 2019-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bariatric surgery	Assess muscle function	Women who have been submitted to a Roux-en-Y Gastric Bypass Surgery for at least 2 years
Unoperated	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

Primary Outcome Measures

Name	Time	Method
Handgrip strength	One time (initial assesment)	Assess handgrip test with a "Jamar®" hydraulic hand dynamometer

Secondary Outcome Measures

Name	Time	Method
Sit and stand	One time (initial assesment)	Number of repetitions of sit ups within 30 seconds
Physical Activity Level	One time (initial assesment)	Assessment with International Physical Activity Questionnaires (IPAQ)

Trial Locations

Locations (1)

University of Chile; 🇨🇱 Santiago, Metropolitana, Chile